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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:
Apr 1, 2024
Recall:
Atovaquone Oral Suspension
Details:
AvKARE, LLC. is voluntarily recalling lot # AW0221A of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in the product found during stability testing at a 3rd party lab.

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, AvKARE 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 between 03/18/2024 through 03/21/2024 Nationwide to Wholesalers.

The product is packaged in a carton. The identified NDC # associated with the product is 50268-086-12, UPC # 5026808612 and the affected lot# is AW0221A with an expiration date of 08/2025.

AvKARE, LLC is notifying its distributors and wholesale customers by mailings and email communications method and is arranging for returns of all recalled Atovaquone Oral Suspension, USP.

Wholesalers who have Atovaquone Oral Suspension, USP 750mg/5mL, which are being recalled, should examine their inventory and cease dispensing, return any of the impacted lots to AvKARE, LLC.

Consumers that have product which is being recalled should stop using the product and return it to place of purchase or discard. Consumers with questions regarding this recall can contact AvKARE by phone at 1-855-361-3993 or email drugsafety@avkare.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 27, 2024
Recall:
Vancomycin Hydrochloride for Oral Solution USP, 250mg/5mL
Details:
Risk Statement: Adult patients who are prescribed the maximum daily dose of up to 2 grams per day of Vancomycin Hydrochloride for oral solution, USP 250 mg/5mL, may receive up to 4 grams of oral vancomycin per day because of the overfilled bottle. Some patients with inflammatory disorders of the intestinal mucosa also may have significant systemic absorption of vancomycin. These patients may be at risk for the development of adverse reactions associated with higher doses of vancomycin oral solution. Worsening renal function could be associated with electrolyte abnormalities such as high potassium leading to cardiac arrest. To date, Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall.

Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL, is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic- associated pseudomembranous colitis caused by C. difficile.

The Vancomycin HCl for Oral Solution, USP, 250 mg/5mL subject to the recall, are identified by the NDC numbers stated on the product label. The following lot numbers of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL are included in this recall.


NDC No.    Lot    Expiration Date    Pack Size
69238-2261-3    22613003A    09/2025    80 mL
69238-2261-7    22613004A    09/2025    150 mL
69238-2261-7    22613005A    09/2025    150 mL
69238-2261-5    22613005B    09/2025    300 mL


The affected Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL lots were distributed Nationwide in the USA directly to Wholesalers and Distributors. The Lots were distributed between 11/09/2023 and 2/20/2024.

Amneal is notifying its direct customers via mail (UPS Standard Overnight) by mailing a recall notification letter and is arranging for the return of the recalled products. Anyone with an existing inventory of the product being recalled should examine the product and quarantine any of the recalled lots immediately.

Customers who purchased the impacted product directly from Amneal may call Amneal at 1-833-582-0812 Monday – Friday, 8:00 am – 5:00 pm, EST, or email to Vancomycin_Recall@amneal.com for further information.

Retailers who have Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL, which are being recalled, should examine their inventory and cease dispensing any of the impacted lots and contact Amneal directly via email at Vancomycin_Recall@amneal.com or by telephone 1-833-582-0812 Monday – Friday, 8:00 am – 5:00 pm, EST, for information and instructions for the product return.

Consumers who have Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/mL should examine the bottle, cease using the product if the lot number is listed on the recall and contact Amneal via telephone or email for recall information and for product return instructions. Consumers may call Amneal at 1-833-582-0812 Monday – Friday, 8:00 am – 5:00 pm, EST, or email Vancomycin_Recall@amneal.com for further information and instructions for the product return. 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.

If you would like to report any adverse reactions or quality problems experienced with the use of this product you may contact Amneal Drug Safety by phone at 1-877-835-5472, Monday - Friday, 8:00 am – 6:00 pm, EST, or via e-mail at DrugSafety@amneal.com.

Any 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.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
FDA Link:
Read more info at FDA.gov
Date:
Mar 22, 2024
Recall:
Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial)
Details:
Risk Statement: Administration of an injectable product that contains particulate matter may result in local irritation or swelling. If the particulate matter reaches the blood vessels or is injected intravascularly 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. To date, Eugia US LLC has not received any reports of adverse events related to this recall.

Methocarbamol injection USP 1000 mg/10 mL (100mg/mL), is used as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. It is packaged in 10 mL and packed as 25 (vials) X 04 (Printed E-Flute cartons) X 01 (Shipper) with NDC code as 55150-223-10. Eugia US LLC shipped the entire lot to wholesalers nationwide from Jan 12, 2024, through Jan 16, 2024.

The product can be identified by product name on carton and vial label and with lot number 3MC23011 and Exp. Date: Nov 2026 (NDC 55150-223-10) (See enclosed vial label).

The product label is as shown below:

Eugia US LLC (f/k/a AuroMedics Pharma LLC) is notifying its distributors by recall letters and is arranging for the return/replacement of all recalled products. Wholesalers, hospitals, pharmacies, institutions, and doctors with an existing inventory of the recalled product lot should discontinue use, stop distribution and quarantine the product immediately. If you have further distributed the recalled product lot, 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.

Consumers with medical questions regarding this recall or to report an adverse event can contact Eugia US LLC from 8:00 am to 5:00 pm (EST) Monday - Friday at:

1-866-850-2876 Option 2
pvg@aurobindousa.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.

If you have any general questions regarding the return of this product, please contact Qualanex at 1-800-505-9291 or email recall@qualanex.com (live calls received 7:00 am to 4:00 pm M-F CST).

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.

Complete and submit the report online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
FDA Link:
Read more info at FDA.gov
Date:
Mar 12, 2024
Recall:
Treprostinil Injection
Details:
Endo International plc announced today that one of its operating companies, Par Pharmaceutical, Inc. (Par), is voluntarily recalling one lot of Treprostinil Injection 20mg/20mL (1mg/mL) to the consumer level. The product is being recalled due to the potential for the presence of silicone particulates in the product solution.

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

Treprostinil Injection is formulated for subcutaneous or intravenous infusion. The product is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension to diminish symptoms associated with exercise and for patients who require transition from epoprostenol to reduce the rate of clinical deterioration.

Treprostinil Injection 20mg/20mL (1mg/mL) is distributed in 20mL multidose vials as sterile solutions in water for injection, individually packaged in cartons under NDC #42023-206-01. Only Lot 57014, expiration date 04/2024 is affected by this recall. The lot was distributed nationwide to wholesalers and hospitals from June 16, 2022, through October 17, 2022.

Vials from the affected lot bear this label: [see below]

Par is providing written notification to wholesale accounts and the hospital location that have received the affected lot and is arranging for return of all existing inventory of Lot 57014 through Inmar, Inc. Wholesale distributors and hospital pharmacies that have the product being recalled should immediately discontinue use and stop distribution immediately. If you have further distributed the recalled product, please notify your accounts or any additional locations which may have received the recalled product.

For information regarding the recall process, call Inmar, Inc. at 1-855-410-3565 Monday through Friday between the hours of 9 am and 5 pm EST. For medical or technical product information or to report a product complaint or adverse event please call 1-800-828-9393.

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:
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

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.