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Navitus is committed to providing high quality services to its members and, as part of this commitment, strives to protect member safety. We have created policies and procedures in the event of drug recalls or situations that pose a threat to the health and safety of our members. We monitor these situations closely and follow the guidelines of the U.S. Food and Drug Administration (FDA).

Read about the drug recall process

Recent drug recalls include:
Date:
Feb 26, 2024
Recall:
Equate Lubricant Eye Ointment, Equate Stye Lubricant Eye Ointment, CVS Health Lubricant Eye Ointment, Lubricant PM Ointment
Details:
Brassica Pharma Pvt. Ltd. is voluntarily recalling Eye Ointment products listed in the table below with expiration date ranging from February 2024 to September 2025. The products are being recalled due to lack of sterility assurance at the facility noted during an inspection conducted by the Food and Drug Administration (FDA).

Risk Statement: For those patients who use these products, there is a potential risk of eye infections or related harm. These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. To date, Brassica Pharma Pvt. Ltd. has not received any reports of adverse events up to 16th February 2024 related to this recall.

Drug-Recall-1.PNG

These products were distributed nationwide to wholesalers, retailers, and via the product distributor, Walmart, CVS and AACE Pharmaceuticals Inc.

Brassica Pharma Pvt. Ltd. Is notifying its distributors AACE Pharmaceuticals Inc and its retailers Walmart and CVS. These distributors shall be further notifying the wholesalers and retailers via mail of this voluntary recall and arranging for return of all impacted products listed above. Consumers, distributors and retailers that have any product which is being recalled should cease distribution of the product. Consumers should stop using the recalled Eye Ointment and may return any of the above listed products to the place of purchase.

Consumers with questions regarding this recall can contact Brassica Pharma Pvt. Ltd. at +1 833-225-9564 or info@brassicapharma.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
FDA Link:
Read more info at FDA.gov
Date:
Jan 22, 2024
Recall:
Eye Drops
Details:
Kilitch Healthcare India Limited Issues Amendments in Last Voluntary Nationwide Recall Press Release

Mumbai, Maharashtra, Kilitch Healthcare India Limited is issuing an amendment in the last Nationwide press release dated November 13, 2023 issued for nationwide recall of various eye drops. There are corrections in product NDC No for the below mentioned products.
Product Product Information NDC NO
(wrongly
Mention is last
press release)
NDC Nos
(Corrected, to
be read as)
Retailer /
Label
LUBRICANT GEL DROPS 15 ML Carboxymethylcellulose Sodium Eye Drops 1.0% W/V 11822-9706-5 11822-4540-5 Rite Aid
LUBRICANT EYE DROPS 15ML (TWIN PACK) Carboxymethylcellulose Sodium Eye Drops 0.5% W/V 11822-9707-5 11822-4811-5 Rite Aid


Consumers with questions regarding this recall can contact regulatory@velocitypharma.com or regulatory@kilitchhealthcare.com Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.


Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

 
FDA Link:
Read more info at FDA.gov
Date:
Jan 8, 2024
Recall:
Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags
Details:
Leiters Health is voluntarily recalling 33 lots of products listed below to the user level. The recalled batches of vancomycin IV bags, phenylephrine IV bags, and fentanyl IV bags are being recalled due to the potential for superpotency because they may contain twice the labeled amount of drug. The semi-automated IV bag filling equipment used to fill the recalled batches may not eject the IV bags properly when compressed air tanks become low or a leak was detected, causing the recalled IV bags to be dosed twice.

Risk Statement: There is a reasonable probability that the use of the defective vancomycin and fentanyl IV bags will be associated with life-threatening adverse events. Administration of vancomycin at twice the infusion rate has been associated with low blood pressure, including shock and cardiac arrest, as well as wheezing, shortness of breath, hives, itchy skin and skin redness. Also, overdosing of vancomycin may be associated with acute kidney injury and ototoxicity. Administration of higher doses of fentanyl than intended can result in profound respiratory depression, which may not automatically be mitigated and treated, resulting in potential for delay in care and serious adverse outcomes from hypoxia, including permanent neurologic sequelae and death. In addition to respiratory depression, fentanyl can cause serious cardiac adverse events, such as hypotension, bradycardia, and vasodilation resulting in decrease in cardiac output and cardiac arrest. In addition, administration of a higher dose of phenylephrine than intended may cause higher-than-intended blood pressures in some patients.

To date, Leiters Health has not received any reports of adverse events related to this recall.
FDA Link:
Read more info at FDA.gov
Date:
Dec 26, 2023
Recall:
4.2% Sodium bicarbonate injection, 8.4% Sodium bicarbonate injection, Atropine sulfate injection
Details:
Hospira, Inc., a Pfizer company, is voluntarily recalling the lots listed in the table below of 4.2% Sodium Bicarbonate Injection, USP ABBOJECT® Glass Syringe, 5 mEq/10 mL; 8.4% Sodium Bicarbonate Injection, USP Lifeshield® ABBOJECT® Glass Syringe, 50 mEq/50 mL; and Atropine Sulfate Injection, USP Lifeshield® ABBOJECT® Glass Syringe, 1 mg/10 mL to the user level. The recall was initiated due to the potential for presence of glass particulate matter, identified during product inspection.

Should a patient receive an injectable product containing glass particulate matter as a result of this issue, the patient may experience serious adverse events. Potential complications related to injection of visible and subvisible inert particles include inflammation of a vein, granuloma, and blockage of blood vessels or life-threatening blood clot events. The frequency and severity of these adverse events could vary depending upon a variety of factors including the size and number of particles in the drug product, patient comorbidities (such as age, compromised organ function), and presence or absence of vascular anomalies.

The risk is reduced by the possibility of detection, as the label contains a clear statement directing the healthcare professional to visually inspect the product for particulate matter and discoloration prior to administration.

To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots.

Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. It is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. It is also indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate.

Atropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by intravenous injection and is indicated for temporary blockade of severe or life-threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
FDA Link:
Read more info at FDA.gov
Date:
Dec 22, 2023
Recall:
Bleomycin for Injection, USP 15 Units Single Dose ONCO-TAIN™ Glass Fliptop Vial
Details:
Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Bleomycin for Injection, USP 15 units Single Dose ONCO-TAIN™ Glass Fliptop Vial, lot BL12206A, to the user level. The recall was initiated due to a confirmed customer report for the presence of glass particulate within a single vial.

Should a patient receive injectable product containing glass particulate matter as a result of this issue, the patient may experience adverse events including injection site reaction, localized vein inflammation or phlebitis, thrombus, embolus and/or end-organ granuloma or life-threatening blood clot events. The risk is reduced by the possibility of detection, as the label contains a statement directing the healthcare professional to visually inspect the product for particulate matter and discoloration prior to administration.

To date, Pfizer has not received reports of any adverse events related to this recall.

Bleomycin for Injection, USP is a mixture of cytotoxic glycopeptide antibiotics isolated from a strain of Streptomyces verticillus. It should be considered a palliative treatment useful in the management of the neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents.

For patients where they, or anyone in close physical contact, do not have a contraindicated device, no action is needed.
 
Product NDC Lot Number Expiration Date Presentation Configuration/Count
Bleomycin for Injection, USP,
15 Units
Single-Dose
ONCO-TAIN™
Glass Fliptop Vial
61703-332-18 BL12206A 30JUN2024 15units/ vial
lyophilized
1 vial per carton,
112 vials per case

Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified direct consignees by letter to arrange for return of any recalled product.

Wholesalers, hospitals, institutions, and doctors with an existing inventory of the lot, which is being recalled, should discontinue use, stop distribution, and quarantine the product immediately. If you have further distributed the recalled product, please notify your accounts and/or any additional locations which may have received the recalled product. Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall. For additional assistance, call Sedgwick Inc. at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

Healthcare Professionals with questions regarding this recall can contact Pfizer using the below information.
 

Contact Center

Contact Information

Area of Support

Pfizer Medical Information 1-800-438-1985, option 3
(9am to 5pm ET Monday
through Friday)
www.pfizermedinfo.comExternal Link Disclaimer
For medical questions
regarding the product
Pfizer Safety 1-800-438-1985, option 1
(24 hours a day;
7 days a week)
To report adverse events
and product complaints

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

FDA Link:
Read more info at FDA.gov
Date:
Dec 22, 2023
Recall:
Americaine® 20% Benzocaine Topical Anesthetic Spray
Details:
Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company (“Insight”), is voluntarily recalling one lot of Americaine® 20% Benzocaine Topical Anesthetic Spray to the consumer level. While benzene is not an ingredient in any Americaine® 20% Benzocaine Topical Anesthetic Spray products, a recent review by our manufacturer and their third-party lab found that a sample from one lot of the product showed a low level of benzene came from the propellant that sprays the product out of the can. Importantly, no other lots of Americaine® 20% Benzocaine Topical Anesthetic Spray (either before or after this batch code) are in the scope of this recall and may continue to be used by consumers safely and as intended.

Risk Statement: Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin and it potentially can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life threatening. Insight is recalling these products out of an abundance of caution. To date, the Company has not received any serious adverse events related to this recall. Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources.

Americaine® 20% Benzocaine Topical Anesthetic Spray is packaged in white aerosol cans with Teal caps with Lot codes located on the bottom of the can.

Samples of the recalled lot below have been found to contain trace levels of Benzene related to the propellant that sprays the product out of the can. Benzene is not an ingredient in any Americaine products.
Product NDC Lot Code Expiration Package Size
Americaine® 20%
Benzocaine Topical
Anesthetic Spray
63736-378-02 1A16420 01/25 2 oz / 57 g
 

The affected Americaine® 20% Benzocaine Topical Anesthetic Spray lot was distributed nationwide in the United States through a limited number of retailers and online.

Insight has notified retailers via overnight mail to remove any remaining recalled product from shelves and follow the instructions provided in the Drug Recall Notification. The company will also offer reimbursement for consumers who have purchased Americaine® 20% Benzocaine Topical Anesthetic Spray marked with the lot code in the table above. Consumers can contact Insight Pharmaceuticals via e-mail at medicalaffairs@prestigebrands.comExternal Link Disclaimer, through its website at https://www.prestigebrands.com/contactExternal Link Disclaimer, or by phone at (800) 344-7239 on Monday – Friday 8:30-5:30 eastern time to receive a full refund by providing a picture of the bottom of the can of the Americaine® 20% Benzocaine Topical Anesthetic Spray with the affected lot number. Consumers that have product which is being recalled should stop using the product immediately and appropriately discard after taking the picture. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this anesthetic product.

No serious adverse events have been reported to date.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. 

FDA Link:
Read more info at FDA.gov
Date:
Dec 11, 2023
Recall:
Vigabatrin for Oral Solution
Details:
InvaGen Pharmaceuticals Issues Voluntary Nationwide Recall of Vigabatrin for Oral Solution, USP 500mg due to Leaking Sachets

Cipla Limited today announced that its wholly-owned subsidiary, InvaGen Pharmaceuticals Inc. is voluntarily recalling one lot of Vigabatrin for Oral Solution, USP 500mg, to the consumer level. Vigabatrin for Oral Solution, USP 500 mg has been found to have seal integrity issues allowing for powder leakage from the pouch.
 
Sr. No. Product Name NDC# Batch No. Expiry Date
1. Vigabatrin for Oral Solution, USP 500mg/sachet 6909-7964-53 NB301030 03/2025


An improper seal in the pouch may lead to the leakage of powder blend outside the pouch, resulting in a lower content of medicine inside the pouch compared to the label claim and result in potential underdosing. The population at risk is primarily infants and young children. In those patients, there is a reasonable probability that inaccurate dosing might result in a serious adverse effect such as intoxication or breakthrough seizures requiring medical intervention. For a small minority of patients, who might have severe or repeated breakthrough seizures, a drop in their phenytoin blood levels could result in life-threatening seizures requiring immediate emergency room treatment. Cipla has not received any reports of adverse events related to this recall.

The product is used for the treatment of Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded adequately to several alternative treatments. Vigabatrin for oral solution is not indicated as a first-line agent. The medication is packaged in foil pouches, each containing 500mg of Vigabatrin, and there are 50 foil sealed pouches in a shelf pack. The affected lot is NB301030, with an expiration date of 03/2025. The Vigabatrin for Oral Solution, USP 500mg product was distributed nationwide to partnered distributors and consignees.

InvaGen Pharmaceuticals is notifying the customer level through press releases, letters, telefax, telephone, email, and on-site visits, and is coordinating the return of all recalled products. Distributors, retailers and consumers in possession of Vigabatrin for Oral Solution, USP 500mg Batch No. NB301030, NDC# 6909-7964-53 are advised to initiate the return process through their respective place of purchase.

Consumers with questions regarding this recall can contact Cipla by phone number 844- CIPLAUS (844-247-5287) M-F 8:30 AM-5:00 PM EST, or email cipla.cs@cipla.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this batch of drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

FDA Link:
Read more info at FDA.gov
Date:
Dec 1, 2023
Recall:
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Details:
Recalled Product
• Product Names: BD Alaris Syringe Module, BD Alaris PCU, and Alaris PCA Module
• Model Numbers: 8110, 8015, 8120
• Distribution Dates: June 19, 2004 to September 22, 2023
• Devices Recalled in the U.S.: 220,120 syringe pump and PCA modules and 867,362 PCU modules
• Date Initiated by Firm: September 15, 2023

Device Use
The Alaris infusion pump is a modular infusion pump system generally intended to deliver medications or other fluids. The syringe and PCA pump modules are validated for use with specific syringes. On the Alaris system, the user enters the nominal volume of the syringe and selects the syringe brand from a library of compatible syringes. This instructs the PCU on which pre-loaded syringe dimensions to use when calculating the volume of fluid in the syringe.

Monoject is one of the most common syringes used with infusion pumps and is specifically mentioned as an example in the Alaris 8015 user manual as shown below.
Alaris-Recall.PNG
 
Reason for Recall
Becton Dickinson (BD)/Carefusion 303 is recalling their Alaris Infusion Pumps due to compatibility issues with Cardinal Health Monoject syringes.

The Alaris pumps are validated for use with ‘Monoject’ syringes and list ‘Monoject’ as one of the options when the user is selecting a syringe type within the Alaris system. However, the dimensions for Monoject syringes have recently changed while rebranding the syringes from “Covidien Monoject” to “Cardinal Health Monoject.” Cardinal Health branded Monoject syringes have not been validated for use with the BD Alaris Syringe and PCA modules. When one of these new syringes is used with the previous syringe settings, the pump may either refuse to operate or incorrectly estimate the volume of liquid in the syringe. This has resulted in over and under infusions, as well as delays in therapy.

Use of incompatible syringe sizes and models with the BD Alaris Syringe and PCA Modules can impact syringe pump operation resulting in inaccurate fluid delivery, delayed generation of occlusion alarms, and other potential problems.

There have been 13 reported injuries. There have been no reports of death.

Alaris-Recall-2.PNG
Figure 1, representative examples of the Covidien Monoject syringes (compatible) on the left, and the Cardinal Health Monoject syringes (not compatible) on the right.

Who May be Affected
• Health care providers using the affected Alaris Pump System with Cardinal Health Monoject syringes
• Patients who receive fluids or medications delivered by the affected Alaris Pump systems with Cardinal Health Monoject syringes

What to Do
On September 15, 2023, Becton Dickinson (BD) sent all affected customers an Urgent Medical Device Labeling Correction.

The letter requested customers to:
• Stop use of Cardinal Health branded Monoject syringes with the BD Alaris Syringe and PCA Modules.
• Replace the current BD Alaris Syringe and PCA Module Compatibility Lists with the updated compatibility lists attached to the letter.
• Complete the Customer Response Form that was attached to the letter and return to the BD contact noted on the form to acknowledge receipt of this notification.

Contact Information
Customers in the U.S. with questions about this recall should contact BD Support Center at 888-562-6018.
FDA Link:
Read more info at FDA.gov
Date:
Nov 27, 2023
Recall:
Novartis Issues Voluntary US Nationwide Recall of Two Lots of Sandimmune® Oral Solution (Cyclosporine Oral Solution, USP), 100 mg/mL Due to Crystallization
Details:
Novartis is conducting a voluntary nationwide recall at the consumer level of two lots of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. The issue was identified during an investigation of crystallization in a different lot of Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL. No other Sandimmune formulations are impacted.

Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL, packaged in 50 mL bottles, is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents.

Risk Statement:
Crystallization of cyclosporine in Sandimmune Oral Solution is likely to result in non-uniform distribution of the cyclosporine in the product, resulting in under-dosing or over-dosing. There is a reasonable probability that under-dosing may result in lower exposures and decrease in efficacy which could ultimately lead to graft rejection and graft loss in transplant patients. Furthermore, over-dosage may manifest itself as cyclosporine toxicity in the long term if over exposure continues. Novartis has not received any reports of adverse events related to this recall, to date.

The affected lot numbers and expiration dates are: FX001500 (expiration date 09/2024) and FX001582 (expiration date 09/2024) NDC 0078-0110-22. These lots were only distributed in the US. They were distributed nationwide to wholesalers across the US, beginning in January 2022 and September 2022, respectively.

Novartis is notifying its distributors via a recall notification letter and is arranging for return of the recalled lot from distributors, retailers, and consumers. Additionally, Novartis is notifying health care providers who have prescribed this product to contact their patients. Consumers that have bottles from the recalled lot of Sandimmune Oral Solution (cyclosporine oral solution, USP), 100mg/mL, should contact their health care provider.

In the event that a patient experiences an adverse reaction or quality problem involving this product, they should immediately contact their health care provider and Novartis to report the event or finding. Patients or health care providers may call the Novartis Customer Interaction Center at 888-NOW-NOVA (888-669-6682) from 8:30 AM - 5:00 PM ET Monday through Friday, or may report an adverse event through https://www.novartis.com/reportExternal Link Disclaimer or usdrugsafety.operations@novartis.com.
 
FDA Link:
Read more info at FDA.gov
Date:
Nov 21, 2023
Recall:
Bayer Issues Voluntary Recall Nationwide of VITRAKVI® (larotrectinib) Oral Solution 20 mg/mL Due to Presence of Microbial Contamination
Details:
Bayer is voluntarily recalling one lot of Vitrakvi® (larotrectinib) Oral Solution 20 mg/mL in 100mL glass bottles to the consumer/user level. The product is being recalled due to microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing.

Risk Statement:
Given that Vitrakvi® is indicated for the treatment of solid tumors that are NTRK gene fusion positive, it is expected that patients on Vitrakvi® may be immunocompromised. Although there is little data in the literature on human pathology caused by Penicillium brevicompactum, there are cases of invasive disease caused by similar Penicillium species, particularly in patients with underlying immunosuppression. Therefore, there is a reasonable probability that ingestion of Penicillium brevicompactum in patients on Vitrakvi® with underlying immunosuppression may result in invasive fungal infections of the blood or pneumonia that can be life-threatening. To date, Bayer has not received any adverse events related to this recall.

The impacted lot of Vitrakvi® is packaged in a 100mL glass bottle with NDC# 50419-392-01 and is identified with Lot# 2114228 and an expiration date of February 29, 2024. Lot# 2114228 was distributed to wholesale distributors and specialty pharmacies nationwide between January 3, 2023, and February 13, 2023.

Product bottle and carton label images and information on the lot number that falls under this recall is available at:

Vitrakvi Recall Lot # Photos 11.17.23.pdf (bayer.com)External Link Disclaimer

Bayer notified all distributors and pharmacies of this recall on November 8, 2023. Bayer has engaged Qualanex to manage the recall of the product down to the consumer level. Qualanex has notified Vitrakvi® distributors via a recall notification letter and will arrange for the return of the recalled lot from distributors, specialty pharmacies, and consumers. Consumers with general questions regarding this recall can contact Qualanex via e-mail at Recall@qualanex.com or toll free at 888-280-2043, Monday-Friday between the hours of 7 a.m. and 4 p.m. Central Standard Time.

Consumers who have the recalled Vitrakvi® product should immediately stop use of this particular lot of product and contact their physician or healthcare provider if they have any questions, concerns or have experienced any problems related to Vitrakvi® Oral Solution 20 mg/mL.

Patients or prescribers who have questions regarding the recall can contact Bayer Medical Information Call Center at 888-842-2937, Monday-Friday between the hours of 8:30 a.m. and 8:00 p.m. Eastern Standard Time.
FDA Link:
Read more info at FDA.gov
Date:
Nov 1, 2023
Recall:
Cardinal Health, Inc. Issues Voluntary Nationwide Recall of Certain LEADER™ Brand Eye Drops Supplied by Velocity Pharma, LLC Due to Potential Risk of Eye Infections
Details:
Cardinal Health, Inc. is initiating a voluntarily recall for all lots of ophthalmic products supplied by Velocity Pharma, LLC to the consumer level. Cardinal Health, Inc. received information from FDA indicating investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility.

Risk Statement: For those patients who use these products, there is a potential risk of eye infections that could result in partial vision loss or blindness. These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drug applied to the eyes bypass some of the body’s natural defenses. To date, Cardinal Health, Inc., and its subsidiaries have received reports of three (3) adverse events related to these listed products. The reports of adverse events were shared with our supplier, Velocity Pharma, LLC.

These products are available as over the counter (OTC) products used for temporary relief of burning and irritation due to dryness of the eye, for use as a protectant against further irritation or to relieve dryness of the eye, and/or to relieve redness of the eye due to minor eye irritations.

These products can be identified on the outer carton labeling as follows:

Capture.PNG

Images of the outer carton labeling of these listed products can be found below.

Products were distributed Nationwide to Wholesalers and Retailers starting December 12, 2021.
Cardinal Health, Inc. is notifying all impacted direct accounts via mail of this voluntary recall and is arranging for return of all recalled products listed above. Wholesalers, Distributors and Retailers that have the affected product which is being recalled should cease distribution of the products. Consumers should stop using the recalled eye drop products and may return any of the above listed products to the place of purchase.

Consumers with questions regarding this recall can contact Sedgwick, Inc. by phone at 1-855-215-4940 (8:00am-5:00pm EST Monday through Friday) or by email at Cardinalhealth7720@sedgwick.com. Consumers who have signs or symptoms of an eye infection after using these products should talk to their health care provider or seek medical care immediately.
 
FDA Link:
Read more info at FDA.gov
Date:
Nov 1, 2023
Recall:
The Harvard Drug Group, LLC Issues Voluntary Nationwide Recall of Certain Rugby® Laboratories Brand Eye Drops Supplied by Velocity Pharma, LLC Due to Potential Risk of Eye Infections
Details:
The Harvard Drug Group, LLC d/b/a Major® Pharmaceutical and Rugby® Laboratories is initiating a voluntarily recall for all lots of Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) supplied by Velocity Pharma, LLC to the consumer level. The Harvard Drug Group, LLC received information from FDA indicating investigator found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility.

Risk Statement: For those patients who use these products, there is a potential risk of eye infections that could result in partial vision loss of blindness. These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drug applied to the eyes bypass some of the body’s natural defenses. The Harvard Drug Group, LLC has received three (3) reports of adverse events related to these products including reports of vision blurriness, vision loss, and burning eyes. The reports of adverse events were shared with our supplier, Velocity Pharma, LLC.

Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) are available as over the counter (OTC) products used for temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun and the product used as a protectant against further irritation or to relieve dryness of the eye.

Both Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) can be identified on the outer carton labeling as follows:

Capture3.PNG

Images of the outer carton labelling of both Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) can be found below.

Products were distributed Nationwide starting June 1, 2021.

The Harvard Drug Group, LLC is notifying all impacted direct accounts via mail of this voluntary recall and is arranging for return of all recalled products listed above. Wholesalers, Distributors and Retailers that have the affected product which is being recalled should cease distribution of the products. Consumers should stop using the recalled eye drop products and may return any of the above listed products to the place of purchase.

Consumers with questions regarding this recall can contact Sedgwick, Inc. by phone at 1- 866-891-1981 (8:00am-5:00pm EST Monday through Friday) or by email address harvarddrug8430@sedgwick.com. Consumers who have signs or symptoms of an eye infection after using these products should talk to their health care provider or seek medical care immediately.




 
FDA Link:
Read more info at FDA.gov
Date:
Oct 25, 2023
Recall:
8.4% Sodium Bicarbonate Injection, USP, Midazolam in 0.8% Sodium Chloride Injection, ELCYS (cysteine hydrochloride Injection), USP
Details:
Exela Pharma Sciences, LLC, (Exela) is voluntarily recalling the products listed in the table below to the consumer level. Particulate matter identified as silicone was observed during routine inspection of retain samples.

Drug-Recall.PNG

Risk Statement: Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. Exela has not received any reports of adverse events related to this recall.

8.4% Sodium Bicarbonate Injection USP is used for treatment of metabolic acidosis and is packaged in a 50 mL glass single dose vials, 20 vials per carton Exela brand (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1, Figure 1) and 25 vials per carton Exela brand (Carton NDC: 51754-5001-4; Vial NDC: 51754-5001-1) and Civica brand (Carton NDC: 72572-740-20; Vial NDC: 72572-740-01, Figure 2).

The affected 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL lots (covering both Exela and Civica brands) include the following lot numbers and expiration dates:

Brand   Lot               Expire Date
Exela    P0001429    11/2023
Exela    P0001900    08/2024
Exela    P0001902    08/2024
Exela    P0001903    09/2024
Exela    P0001909    09/2024
Civica   P0001912    08/2024
Exela    P0001945    09/2024
Exela    P0002002    11/2024
Exela    P0002052    12/2024

Product was distributed nationwide to wholesalers, distributors, and health systems between January 18, 2022 and February 15, 2023.

Midazolam in 0.8% Sodium Chloride Injection is used for sedation and is packaged in a 100 mL glass vial, 25 vials per corrugated shipper. The vials are labeled with Exela brand (Carton NDC: 51754-2131- 4; Vial NDC: 51754-2131-1, Figure 3).

The affected Midazolam in 0.8% Sodium Chloride Injection 100 mg/ 100 mL include the following lot number and expiration date:

Brand    Lot             Expire Date
Exela    10001088    07/2024

Product was distributed nationwide to wholesalers, distributors, and health systems between July 14, 2023, and September 26, 2023.

ELCYS (cysteine hydrochloride Injection) is used for nutritional requirements per total parenteral nutrition (TPN) and is packaged in a 10 mL glass vial, 10 vials per carton. The vials are labeled with Exela brand (Carton NDC: 51754-1007-3; Vial NDC: 51754-1007-1, Figure 4).

The affected ELCYS (cysteine hydrochloride Injection), USP 50 mg/mL includes the following lot number and expiration date:

Brand    Lot             Expire Date
Exela    10000798    03/2025

Product was distributed nationwide to wholesalers, distributors, health systems, and compounders between July 20, 2023, and August 1, 2023.

Exela is notifying its customers by e-mail and certified mail and is arranging for return and replacement of all recalled product directly to Exela. Customers that have product which is being recalled should discontinue use, segregate the recalled product, submit a recall stock response form to Exela (even if there is no product to return), and hold the product until shipment instructions are provided by Exela.

Customers with questions regarding this recall can contact Exela by phone (828-341-6118) or email at recall@exela.us Monday through Friday, 9:00am – 5:00pm ET. Consumers should contact their physician or healthcare provider if they have experienced any problems related to the usage of this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
FDA Link:
Read more info at FDA.gov
Date:
Oct 2, 2023
Recall:
4.2% Sodium Bicarbonate Injection, USP and 1% and 2% Lidocaine HCl Injection, USP
Details:
Hospira, Inc., a Pfizer company, is voluntarily recalling the lots listed in the table below of 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10mL vial; 1% Lidocaine HCl Injection, USP, 50 mg/5mL vial; and 2% Lidocaine HCl Injection, USP, 100 mg/5mL vial to the user level. The recall was initiated due to the potential for presence of glass particulate matter.

There is an unlikely probability for serious adverse events, including death, should a patient receive an injectable product found to contain particulate matter identified as glass. Potential complications related to injection of visible and subvisible inert particles include inflammation of a vein, granuloma, and blockage of blood vessels or life-threatening blood clot events. The frequency and severity of these adverse events could vary depending upon a variety of factors including the size and number of particles in the drug product, patient comorbidities (such as age, compromised organ function), and presence or absence of vascular anomalies. The risk is reduced by the possibility of detection, as the label contains a clear statement directing the healthcare professional to visually inspect the product for particulate matter and discoloration prior to administration.

To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots.

Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. It is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. It is also indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate.

Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of an antiarrhythmic agent administered intravenously by either direct injection or continuous infusion. It is available in various concentrations. It is administered intravenously or intramuscularly and is specifically indicated in the acute management of ventricular arrhythmias such as those occurring in relation to acute myocardial infarction, or during cardiac manipulation, such as cardiac surgery.

The NDC, Lot Number, Expiration Date, and Configuration details for the impacted products are indicated below. The products were distributed nationwide to wholesalers/hospitals/institutions in the United States and Puerto Rico from October 13, 2022 through October 26, 2022.

Table-1-(1).PNG

Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified direct consignees by letter to arrange for the return of any recalled product.

Wholesalers, hospitals, institutions, and doctors with an existing inventory of a lot which is being recalled should discontinue use, stop distribution and quarantine the product immediately. If you have further distributed the recalled product, please notify your accounts and/or any additional locations which may have received the recalled product. Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall. For additional assistance, call Sedgwick Inc. at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

Healthcare Professionals with questions regarding this recall can contact Pfizer using the information below.

Table-2.PNG

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
FDA Link:
Read more info at FDA.gov
Date:
Sep 27, 2023
Recall:
BREXAFEMME® (ibrexafungerp tablets)
Details:
SCYNEXIS Issues a Voluntary Nationwide Recall of BREXAFEMME® (ibrexafungerp tablets) Due to
Potential for Cross Contamination with a Non‐Antibacterial ßlactam Drug Substance

Description:
SCYNEXIS, Inc. is conducting a voluntary nationwide recall of 2 lots of BREXAFEMME®
(ibrexafungerp tablets) to the consumer level in the US market due to potential cross contamination with a
non- antibacterial ß-lactam drug substance in the ibrexafungerp citrate used to manufacture the
BREXAFEMME® tablets. During a review of manufacturing equipment and cleaning activities at a
supplier, SCYNEXIS was made aware of potential cross-contamination risk with a non-antibacterial betalactam
drug substance. This press release provides additional details on the voluntary product recall
recently disclosed by SCYNEXIS.

Risk Statement: The potential cross contamination with a non-antibacterial beta-lactam drug substance
could lead to hypersensitivity reactions such as swelling, rash, urticaria and anaphylaxis, a potentially life threatening adverse reaction. To date, SCYNEXIS has not received any reports of adverse events
established to be due to the possible beta-lactam cross contamination.
BREXAFEMME® is an antifungal product indicated for the treatment of vulvovaginal candidiasis (VVC)
and the reduction of the incidence of recurrent vulvovaginal candidiasis (RVVC).

Description:
BREXAFEMME® is dispensed in a carton and packaged in blister packs with four 150-mg tablets (NDC
75788-115-04). BREXAFEMME® tablet for oral administration is a purple, oval, biconvex shaped, filmcoated
tablet debossed with 150 on one side and SCY on the other side. The affected BREXAFEMME® lots
include the following lots and expiration dates: LF21000008 (expiration date 11/2023) and LF22000051
(expiration date 11/2025). The recalled lots were distributed nationwide to wholesalers across the US,
beginning in December 2022.

SCYNEXIS is engaging with Sedgwick to manage the recall of the product down to the consumer level.
Sedgwick will be notifying BREXAFEMME® distributors via a recall notification letter and will be
arranging for the return of the recalled lot from distributors, retailers, and consumers.
Consumers with questions regarding this recall can contact Sedgwick at 1-877-551-7154. Office hours:
Monday to Friday, 8:00 AM to 5:00 PM ET.

Consumers should contact their healthcare provider if they have experienced any problems that may be
related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the
FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
FDA Link:
Read more info at FDA.gov
Date:
Sep 11, 2023
Recall:
Sandimmune® Oral Solution
Details:
Novartis is conducting a voluntary nationwide recall at the consumer level of one lot of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. No other Sandimmune formulations are impacted.

Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL, packaged in 50 mL bottles, is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents.

Risk Statement: Crystallization of cyclosporine in Sandimmune Oral Solution is likely to result in non-uniform distribution of the cyclosporine in the product, resulting in under-dosing or over-dosing.  There is a reasonable probability that under-dosing may result in lower exposures and decrease in efficacy which could ultimately lead to graft rejection and graft loss in transplant patients. Furthermore, over-dosage may manifest itself as cyclosporine toxicity in the long term if over exposure continues. Novartis has not received any reports of adverse events related to this recall, to date.

The affected lot number and expiration date is: FX001691 (expiration date 12/2025). This lot was distributed nationwide to wholesalers across the US, beginning in April 2023.

Novartis is notifying its distributors via a recall notification letter and is arranging for return of the recalled lot from distributors, retailers and consumers.  Additionally, Novartis is notifying health care providers who have prescribed this product to contact their patients.  Consumers that have bottles from the recalled lot of Sandimmune Oral Solution (cyclosporine oral solution, USP), 100mg/mL, should contact their health care provider.

In the event that a patient experiences an adverse reaction or quality problem involving this product, they should immediately contact their health care provider and Novartis to report the event or finding. Patients or health care providers may call the Novartis customer interaction center at 888-NOW-NOVA (888-669-6682) from 8:30 AM - 5:00 PM ET Monday through Friday or may report an adverse event through https://www.novartis.com/reportExternal Link Disclaimer or usdrugsafety.operations@novartis.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
FDA Link:
Read more info at FDA.gov
Date:
Jul 31, 2023
Recall:
Tydemy
Details:
Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of 2 Lots of TydemyTM (Drospirenone, Ethinyl Estradiol & Levomefolate Calcium Tablets 3mg/0.03mg/0.451mg and Levomefolate Calcium Tablets 0.451mg)

Lupin Pharmaceuticals Inc. (Lupin) is voluntarily recalling two (2) lots of Tydemy (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451 mg and Levomefolate Calcium Tablets 0.451 mg) to the patient (consumer/user) level due to out of specification (OOS) test results at the 12-month stability time point.  Specifically, one lot (L200183) tested low for ascorbic acid (an inactive ingredient) and high for a known impurity.

To date, Lupin has received no reports of adverse events related to either recalled batches.  Regardless, Lupin is recalling these two batches because if there were a significant reduction in the amount of inactive content (ascorbic acid), this could potentially impact the effectiveness of the product which could potentially result in unexpected pregnancy.

Tydemy is estrogen/progestin oral contraceptive (COC) indicated for use by women to prevent pregnancy and to raise folate levels in women who choose to use an oral contraceptive for contraception. Tydemy is packaged in 28’s blister. One such blister was then packed in a pouch along with one printed sleeve, one pack insert (with day label) and one oxygen absorber (Stabilox) sachet. The three pouches were packed in one carton.
FDA Link:
Read more info at FDA.gov
Date:
Jul 7, 2023
Recall:
Albuterol Sulfate Inhalation Aerosol
Details:
Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as "Cipla"), today announced that its wholly-owned subsidiary Cipla US is voluntarily recalling six batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) manufactured in November 2021 to the consumer level.
 
Sr. No. Product Name Batch No. Expiry Date
1. Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) IB20045 Nov.2023
2. Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) IB20055 Nov.2023
3. Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) IB20056 Nov.2023
4. Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) IB20057 Nov.2023
5. Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) IB20059 Nov.2023
6. Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) IB20072 Nov.2023


Risk Statement: There is a reasonable probability that failure to deliver the recommended dose to treat the respiratory symptoms of an acute asthma exacerbations such as wheezing coughing, shortness of breath and bronchospasms, due to device defect, may be life-threatening. There were no adverse events reported for Albuterol Sulfate Inhalation Aerosol 90 mcg related to this recall.

The company is initiating a recall in the US due to a market complaint for one single inhaler (Batch Number - IB20056), where leakage was observed through the inhaler valve. Out of an abundance of precaution, the above mentioned 6 batches manufactured using the same lot of valves are being recalled.

The product is used for the treatment and prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise induced bronchospasm. The product is packaged in 17ml plain aluminium aerosol canister integrated with dose counter coupled with plastic actuator and dust cap, each pack claims 200 metered inhalations and associated codes NDC-69097-142-60. These 6 batches were distributed Nationwide to wholesalers and retailers.

Cipla is notifying its distributors and customers by letter and is arranging for return and replacement of all recalled products. Consumers/distributors/retailers that have product from these 6 batches which are being recalled should stop using/return to place of purchase/discard.

Consumers with questions adverse reactions or quality problems regarding these 6 batches can contact Cipla Customer Service at 844- CIPLAUS (844-247-5287) M-F 8:30-5:00 EST, or email cipla.cs@cipla.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
 

FDA Link:
Read more info at FDA.gov
Date:
May 8, 2023
Recall:
Tainted Arthritis - Pain Products
Details:
FDA is notifying consumers of certain products promoted for arthritis and pain management that have been found to contain hidden ingredients and may pose a significant health risk. The public notifications listed below include those products FDA testing found to contain active drug ingredients not listed on the product labels, including some with ingredients found in prescription drugs. These products may cause potentially serious side effects and may interact with medications or dietary supplements a consumer is taking. Consumers should use caution when considering purchasing these types of products.

It is clear from the results of our decade of testing that retailers and distributors, including online marketplaces, do not effectively prevent these types of potentially harmful products from being sold to consumers. FDA cannot test all products on the market that contain potentially harmful hidden ingredients. Enforcement actions and consumer advisories for tainted products only cover a small fraction of the tainted over-the-counter products on the market.

FDA encourages consumers and health care professionals to report any adverse events to the agency’s MedWatch Adverse Event Reporting program so the agency can take action to protect the public from any unsafe products. FDA is committed to protecting consumers from the risks of buying medicines online and helping them be more aware of how to buy online safely.
FDA Link:
Read more info at FDA.gov
Date:
May 4, 2023
Recall:
Various Human and Animal Drug Products
Details:
May 2, 2023 - Gurnee, IL, Akorn Operating Company LLC has filed Chapter 7 bankruptcy on February 23, 2023. In connection with that filing, the company has ceased and shutdown all operations and terminated all its employees of all domestic US Sites. The Akorn Trustee is initiating a voluntary recall of various within-expiry human and animal products as a result of the closures and discontinuation of the Quality activities of these marketed products. (Refer to Attachment I and II*). The discontinuation of the Quality program means the company will not be able to support or guarantee that the products will meet all intended specifications through the labeled shelf life of the product. Further distribution or use of any remaining product on the market should cease immediately.

Risk Statement: The discontinuation of the Quality program would result in the company’s inability to assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess which render the products adulterated. While specific risks to patients, from use of these adulterated products, cannot always be identified or assessed, it is also not possible to rule out patient risks resulting from the use of such products. Akorn has not received any reports of adverse events related to this recall.

The affected products are listed in Attachment I (human drugs) and II (animal drugs) of this release. Only products listed in the attachments are affected by the recall. Products not included in the press are continuing to be monitored under a Quality Program and will remain on the market. The products were distributed nationwide to Wholesalers, Retailers, Manufacturers, Medical Facilities, and Repackagers and via the Internet to Consumers.

Akorn is notifying its distributors and direct consignees by direct mailing and is requesting they further notify their customers/consumers/retailers. Akorn is requesting destruction of any recalled products. Consumers/distributors/retailers that have products which are being recalled should discard and contact their doctor.

Consumers with questions regarding this recall can contact Akorn at (800) 932-5676 during normal business hours (8am – 5pm CDT) Monday – Friday. A qualified medical professional will return your call within one business day. Consumers should contact their physician, their healthcare provider or veterinarian if they, or animals in their care, have experienced any problems that may be related to taking or using these drug products.

For human drug products, adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. For animal drug products, adverse reactions or quality problems experienced with the use of animal drug products may be reported to FDA’s Center for Veterinary Medicine Adverse Event Reporting program by completing an online Form FDA 1932a available at www.fda.gov/reportanimalae.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

* Only products listed in the attachments are affected by the recall. Products not included in the press are continuing to be monitored under a Quality Program and will remain on the market.

Attachment I - List of Human Products (PDF - 231KB)

Attachment II – List of Veterinary Products (PDF - 220KB)
 
FDA Link:
Read more info at FDA.gov
Date:
May 4, 2023
Recall:
SD Biosensor Pilot COVID-19 At-Home Tests
Details:
The U.S. Food and Drug Administration (FDA) is warning consumers and health care providers to stop using and throw out certain lots of recalled SD Biosensor, Inc. Pilot COVID-19 At-Home Tests, distributed by Roche Diagnostics. The FDA has significant concerns of bacterial contamination in the Pilot COVID-19 At-Home Test liquid solution, provided in the test kit. Direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performance of the test.

SD Biosensor, Inc. has initiated a recall for all impacted SD Biosensor Pilot COVID-19 At-Home Tests that were distributed by Roche Diagnostics to certain retailers in the United States. Approximately 500,000 tests were distributed to CVS Health, as well as about 16,000 tests to Amazon. The FDA is working with Roche Diagnostics to understand how many of those tests were sold to consumers.   

Importantly, none of the impacted lots were distributed through COVID.gov/tests - Free at-home COVID-19 tests or as part of other federal testing programs. If you received your tests through the COVID.gov/tests distribution or as part of other federal testing programs, they are not subject to this safety communication or product recall.

The FDA is advising consumers to stop using and throw out Pilot COVID-19 At-Home Test kits with the following lot numbers:
 
53K38N1T1 53K4221T1 53K4292T1
53K38N2T1 53K4222T1 53K42A1T1
53K38N3T1 53K4223T1 53K42A2T1
53K38N4T1 53K4224T1 53K42A3T1
53K38N5T1 53K4225T1 53K42E1T1
53K38P1T1 53K4231T1 53K42G1T1
53K38P2T1 53K4232T1 53K42G2T1
53K38P3T1 53K4233T1 53K42H1T1
53K41T5T1 53K4261T1 53K42H2T1
53K41X1T1 53K4262T1 53K42L1T1
53K41X2T 53K4271T1 53K42L2T1
53K41X3T1 53K4272T1 53K4361AC
53K4211T1 53K4273T1 53K4362AC
53K4212T1 53K4274T1 53K4392AC
53K4213T1 53K4291T1  

Recommendations for Consumers, Test Users, and Caregivers
  • Check to see if your SD Biosensor Pilot COVID-19 At-Home Test is included in the SD Biosensors product recall by comparing the lot number. 
  • Do not use test kits with the affected lot numbers listed above. Throw out the entire test kit in the household trash.  Do not pour the liquid solution down the drain. Additional information can be found in the Quick Reference Instructions for patients. 
  • If the liquid in the tube contacts your skin and eyes, flush with large amounts of water. If irritation persists, seek medical attention.
  • Watch for signs of bacterial infection caused by exposure to the contaminated liquid solution. If you see signs of infection, such as fever, discharge, red eyes, or any other concerning symptoms, seek medical attention.
  • Talk to your health care provider if you think you were tested with an affected Pilot COVID-19 At-Home Test, or if you have concerns about your test results.

Recommendations for Health Care Providers and Testing Program Organizers
  • If an antigen test was performed less than two weeks ago using the Pilot COVID-19 At-Home Test, consider retesting your patients using an FDA authorized or cleared SARS-CoV-2 diagnostic test if you suspect an inaccurate result. If testing was performed more than two weeks ago and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest.
  • If a patient presents with signs of bacterial infection, such as fever, conjunctivitis, or other signs or symptoms of systemic infection, consider whether they have recently used a Pilot COVID-19 At-Home Test.  If they have, consider whether their infection may be from exposure to the contaminated buffer solution.
  • Report any problems you experience with the Pilot COVID-19 At-Home Test to the FDA, including suspected false results. See Reporting Problems with Your Test.

Potential Risks 
The liquid solution provided in the affected Pilot COVID-19 At-Home Test kits has been found to be contaminated with organisms such as Enterococcus, Enterobacter, Klebsiella and Serratia species. Individuals performing the self-test may run the risk of direct contact with the contaminated liquid in the tube. The liquid is contained in an individual, ready-to-use, pre-filled and sealed tube, but a user may inadvertently come in direct contact with contaminated liquid buffer during opening the tube or handling of the open tube or while performing the test.

Infection from bacteria such as Enterococcus, Enterobacter, Klebsiella and Serratia species may cause illness in people with weakened immune systems or those with direct exposure to the contaminated liquid solution through standard handling, accidental spills, or misuse of the product.  

In addition to the risk of infection, this contamination may impact the performance of the test, and false results may occur.
  • A false-negative antigen test result means that the test says the person does not have COVID-19 but they actually do have COVID-19. A false-negative result may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2, which may cause people harm including serious illness and death. False-negative results can also lead to further spread of the SARS-CoV-2 virus, including when people are housed together in health care, long-term care, and other facilities due to these false test results. When false negative test results are received, actions to limit exposure to an infected person might not be taken, such as isolating people, limiting contact with family and friends, or limiting access to places of employment.
  • A false-positive antigen test result means that the test says the person has COVID-19 but they actually do not have COVID-19. A false-positive result may lead to a delay in both the correct diagnosis and appropriate treatment for the actual cause of a person's illness, which could be another life-threatening disease that is not COVID-19. False-positive results could also lead to further spread of the SARS-CoV-2 virus when presumed positive people are housed together.
The FDA has not received reports of injuries, adverse health consequences, or death associated with use of the SD Biosensor Pilot COVID-19 At-Home Test to date.

Test Description 
The SD Biosensor Pilot COVID-19 At-Home Test is a lateral flow immunoassay device intended for the qualitative detection of the nucleocapsid protein antigen found in the SARS-CoV-2 virus. This test is authorized for non-prescription home use, self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older.

FDA Actions
The FDA is currently reviewing the SD Biosensor Pilot COVID-19 At-Home Tests recall and is in the process of classifying the recall risk. The FDA is continuing to work with SD Biosensor Inc. to assess the company’s corrective actions to address the reason for bacterial contamination and help ensure the situation is resolved and will not return. 

The FDA will continue to keep the public informed of significant new information.

Reporting Problems with Your Device
If you think you had a problem with the SD Biosensor Pilot COVID-19 At-Home Test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form

Generally, as specified in a test's Emergency Use Authorization, device manufacturers must comply with the applicable Medical Device Reporting (MDR) regulations.

Questions?
If you have questions, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.

Additional Resources
FDA Link:
Read more info at FDA.gov
Date:
May 4, 2023
Recall:
Specific Pilot COVID-19 At-Home Tests
Details:
SD Biosensor, Inc. today is requesting that consumers stop using and dispose of specific Pilot COVID-19 At-Home Tests in the United States because potentially harmful bacteria were found in the tube with liquid inside (pouch 2 of the kits).

The affected tests can be identified by the lot number on the outer packaging and should be appropriately discarded. Dispose of the entire test kit in the household trash. Do not pour the liquid down the drain.

Direct exposure to the liquid in the tube through misuse or spillage could potentially lead to serious illness.

To date, no such illness has been reported. If the liquid in the tube contacts your skin and eyes, flush with large amounts of water and if irritation persists, seek medical attention.

The affected test kits were distributed by Roche Diagnostics to distributors and retailers in the U.S. Product images, lot information and follow-up actions are available at go.roche.com/pilottestExternal Link Disclaimer or by contacting the Roche Customer Support Center at 1-866-987-6243 and selecting option 1.
The Pilot COVID-19 At-Home Test is an over-the-counter rapid antigen test and uses a nasal swab sample that can be self-collected and self-tested by individuals ages 14 years and older, and by an adult for children ages 2 to 13 years old.

Individuals performing the self-test may run the risk of direct contact with the contaminated liquid in the tube. The liquid is contained in an individual, ready-to-use, pre-filled and sealed tube, but a user may inadvertently come in direct contact with the contaminated liquid during opening the tube or handling of the open tube or while performing the test.

This request to discontinue use and dispose of the affected tests is currently isolated to specific lots of the Pilot COVID-19 At-Home Test, distributed by Roche Diagnostics, exclusively in the U.S. Roche-branded rapid antigen tests authorized in markets outside of the U.S. are unaffected.

You may report adverse events such as unexpected side effects or injury or product quality problems to the U.S. Food and Drug Administration's (FDA's) MedWatch Adverse Event Reporting program in the following ways:

Online: Complete and submit a report on this FDA webpage.

Standard mail or fax: Download this form or call 1-800-332-1088 to request a form. Then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

For more information, please view MedWatch Online Voluntary Reporting Form (fda.gov). This action is being taken with the knowledge of the FDA.
FDA Link:
Read more info at FDA.gov
Date:
Apr 6, 2023
Recall:
FreeStyle Libre, FreeStyle Libre 14 day, FreeStyle Libre 2 Flash Glucose Monitoring Systems
Details:

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product
 

  • Product Name: FreeStyle Libre Flash Glucose Monitoring System, FreeStyle Libre 14 day Flash Glucose Monitoring System, FreeStyle Libre 2 Flash Glucose Monitoring System
  • Product Models: all Reader serial numbers
  • Distribution Dates: Beginning November 2017 – February 2023
  • Devices Recalled in the U.S.: 4,210,785
  • Date Initiated by Firm: February 13, 2023

Device Use

The FreeStyle Libre, Libre 14 day, and Libre 2 Flash Glucose Monitoring Systems are intended to provide continuous monitoring of glucose levels. These devices help people manage diabetes by detecting trends and tracking patterns in glucose levels so treatment can be adjusted as needed. They are used in place of other blood glucose meters, are for single patient use, and require a prescription.

Reason for Recall

Abbott is recalling the FreeStyle Libre, Libre 14 day, and Libre 2 Flash Glucose Management Systems because the systems' reader devices, which use rechargeable lithium-ion batteries, may get extremely hot, spark, or catch on fire if not properly stored, charged, or used with its Abbott provided USB cable and power adapter. This does not affect any of the FreeStyle Libre family of sensors.

The potential for overheating, spark or fire may occur when charging the Reader with non-Abbott adapters or non-Abbott USB cables along with misuse of the Reader and its components. Examples of misuse include exposure to liquids, damage, and introduction of foreign material into the ports.

The Abbott-provided USB cable and power adapter limit the current to safely charge the battery, whereas USB cables and power adapters manufactured by a third party may allow much higher power, increasing the risk of fire.

The Reader, if not properly stored, charged, or used with its Abbott provided USB cable and power adapter, may expose users to extreme heat and/or fire which can cause serious injuries or death. Additionally, users may delay or miss a critical diabetes treatment if the system cannot be used after is damaged by extreme heat.

Abbott reports 206 incidents, including at least seven fires, one injury, and no deaths involving this issue.

Who May be Affected
 

  • People who monitor their glucose levels using the FreeStyle Libre, Libre 14 day, or Libre 2 Glucose Monitoring Systems.
  • Health care providers with patients who use FreeStyle Libre, Libre 14 day, or Libre 2 systems to monitor their glucose levels.

What to Do

On February 13, 2023, Abbott sent some users of the FreeStyle Libre family of Readers an Urgent Medical Device Correction letter.

The FDA recommends:

Stop using the FreeStyle Glucose Monitoring Systems and switch to a back-up method if:
 

  • You do not have the Abbott provided USB cable and power adapter (charger)
  • The Reader appears damaged or cracked
  • If there is visible swelling of the Reader
  • If the Reader gets too hot to hold
  • If the Reader is no longer able to hold a charge (for example, does it turn off unexpectedly or immediately after charging?)
  • If the Reader is damaged or a replacement USB cable or power adapter are needed, call Abbott's Customer Service at 1-855-632-8658 to request a replacement.

To avoid the potential for battery swelling, leakage, extreme overheating and/or fire, Abbott recommends the following:

  • Charge the Reader battery by ONLY using the Abbott supplied USB cable and adapter (charger). Photos are included on www.FreeStyleBattery.comExternal Link Disclaimer to help identify Abbott cables and adapters.
  • DO NOT expose the Reader, power adapter or yellow USB cable to water or other liquids.
  • Store the Reader between -4 °F and 140 °F.
  • DO NOT place the Reader in water or other liquids.
  • Avoid getting dust, dirt, blood, control solution, water, bleach, or any other substance in the test strip or USB port.
  • Review the revised user guide and labeling here at www.freestyle.abbott/us-en/supportExternal Link Disclaimer
  • Visit www.FreeStyleBattery.com to follow steps to perform a Reader Test to determine if your current Reader needs to be replaced

Contact Information
Users with questions about this recall should contact Abbott Customer Service at 1-855-632-8658, available 7 days a week from 8AM to 8PM Eastern Time, excluding major holidays.

FDA Link:
Read more info at FDA.gov
Date:
Mar 31, 2023
Recall:
Atovaquone Oral Suspension USP 750mg/5mL
Details:
Piscataway, NJ, Camber Pharmaceuticals, Inc. is voluntarily recalling lot # E220182 of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in the product.

Risk Statement: In the population most at risk, immunocompromised population, there is a reasonable probability that microbial contamination of Atovaquone Oral Suspension can result in disseminated, life threatening infections such as endocarditis and necrotizing soft tissue infections. To date, Camber has not received any reports of adverse events related to this recall.

Atovaquone Oral Suspension, USP is indicated for prevention and treatment of Pneumocystis jiroveci pneumonia (PCP) in adults and children 13 years of age and older who cannot tolerate other medicines, such as trimethoprim-sulfamethoxazole.

Atovaquone Oral Suspension, USP was distributed Nationwide to Wholesalers, Distributors, Retail Pharmacies, and Mail Order Pharmacies.

The product is packaged in 210mL HDPE bottle in a mono carton. The identified NDC # associated with the product is 31722-629-21, UPC # 331722629218, and the affected lot# is E220182 with an expiration date of 12/2023.

Camber Pharmaceuticals, Inc. is notifying its distributors and customers by our Reverse Logistics Company, Inmar, by mailings and emails communications method and is arranging for returns of all recalled Atovaquone Oral Suspension, USP.

Consumers/distributors/retailers that have product which is being recalled should stop using/return to place of purchase/discard/contact their doctor, etc.

Consumers with questions regarding this recall can contact Inmar by phone at 1-877-597-0878 or email rxrecalls@inmar.com, Monday – Friday, 9am – 5pm Eastern Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

 
FDA Link:
Read more info at FDA.gov
Date:
Mar 22, 2023
Recall:
Dabigatran Etexilate Capsules
Details:
Parsippany. New Jersey. Ascend Laboratories LLC. is voluntarily recalling Dabigatran Etexilate Capsules. USP 75 mg and 150 mg to the consumer/user level due to the presence of a nitrosamine. N-nitroso-dabigatran, above the established Acceptable Daily Intake (ADI) level. To date, Ascend Laboratories LLC., has not received any reports of adverse events related to this recall.

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.

The product is used as an oral anticoagulant to lower the risk of stroke and blood clots.

The NDC. Lot Number. Expiration Date. and Packaging Configuration details for Dabigatran Etexilate Capsules that are subjected to this recall are indicated in the table belov,:. The product lots were distributed nationwide to wholesalers, Distributors and Retailers (dispensers) in the United States from June 2022 to October 2022.
 
Product NDC Lot Number Expiration Date Presentation Configuration/Count
Dabigatran Etexilate
Mesylate Caps 150
Mg
67877-475-60 22142448 MAY.2024 HDPE
Bottles
60
capsules/bottle
Dabigatran Etexilate
Mesylate Caps 150
Mg
67877-475-60 22142449 MAY.2024 HDPE Bottles 60 capsules/bottle
Dabigatran Etexilate
Mesylate Caps 150
Mg
67877-475-60 22142450 MAY.2024 HDPE Bottles 60 capsules/bottle
Dabigatran Etexilate
Mesylate Caps 75 Mg
67877-474-60 22142462 MAY.2024 HDPE Bottles 60 capsules/bottle
Dabigatran Etexilate
Mesylate Caps 75 Mg
67877-474-60 22142463 MAY.2024 HDPE Bottles 60 capsules/bottle
Dabigatran Etexilate
Mesylate Caps 75 Mg
67877-474-60 22142464 MAY.2024 HDPE Bottles 60 capsules/bottle
Dabigatran Etexilate
Mesylate Caps 75 Mg
67877-474-60 22143000 JUN.2024 HDPE Bottles 60 capsules/bottle
Dabigatran Etexilate
Mesylate Caps 75 Mg
67877-474-60 22143001 JUN.2024 HDPE Bottles 60 capsules/bottle
Dabigatran Etexilate
Mesylate Caps 75 Mg
67877-474-60 22143002 JUN.2024 HDPE Bottles 60 capsules/bottle
Dabigatran Etexilate
Mesylate Caps 150
Mg
67877-475-60 22143845 JUL.2024 HDPE Bottles 60 capsules/bottle

Wholesalers/distributors and pharmacies with an existing inventory of the lots listed in the table above, should stop use and distribution and quarantine the product immediately. Wholesalers and Distributors are advised to recall the distributed product. Please notify any accounts or additional locations that may have received the recalled product from you. Please conduct a sub-recall to those accounts and communicate this recall information immediately. Ascend requests that they immediately cease distribution of the affected product. Patients who have received impacted lots of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment. Consumers with questions regarding this recall can contact Ascend Laboratories LLC. using the below information.
 
Contact Center Contact Information Area of Support
Ascend Laboratories, LLC 877-272-7901, 24 hrs., 7 days a week To report adverse events and product complaints

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Customers with medical-related questions, who wish to report an adverse event, or quality issues about the products being recalled should contact Ascend Laboratories LLC., by phone at: 877- 272-7901, 24 hrs., 7 days a week. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.  
FDA Link:
Read more info at FDA.gov
Date:
Mar 1, 2023
Recall:
Brimonidine Tartrate Ophthalmic Solution
Details:

Apotex Corp., with the knowledge of the US FDA, is initiating a voluntary recall at the Consumer level for six (6) lots of Brimonidine Tartrate Ophthalmic Solution, 0.15%. This recall is being initiated out of an abundance of caution due to cracks that have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility and if so, the possibility of adverse events.

Brimonidine Tartrate Ophthalmic Solution is an alpha-adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Lot numbers are listed at fda.gov.

FDA Link:
Read more info at FDA.gov

Disclaimer: Navitus Health Solutions, LLC is a transparent Pharmacy Benefit Manager for a variety of health care plans. Navitus is not owned or operated by an entity related to the pharmaceutical manufacturing industry. Navitus is also not responsible for the manufacture, distribution or recall of any medication. This notification is meant solely to provide information to our clients, members and policyholders, regarding the various recalls of medications by the FDA. Navitus assumes no liability for the information contained in these notifications.