FDA MedWatch - Metformin HCl Extended- Release Tablets USP, 750 mg by Viona Pharmaceuticals:

U.S. Food and Drug Administration sent this bulletin at 01/13/2022 06:47 AM EST

If your email program has trouble displaying this email, view as a webpage.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

TOPIC: Metformin HCl Extended- Release Tablets USP, 750 mg by Viona Pharmaceuticals: Recall - Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

AUDIENCE: Patient, Health Professional, Pharmacy

ISSUE: Viona Pharmaceuticals is recalling twenty-three (23) lots of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg because an Out of Specification (OOS) result observed for one lot of the product (M008132) “N-nitrosodimethylamine (NDMA) (By GC- MS/MS)” test at 17 Month(s), 25°C/60%RH Long-term stability samples. In an abundance of caution, the firm has decided to recall 23 batches which have determined having a valid shelf life within the US market. This product was manufactured by Cadila Healthcare Limited, Ahmedabad, India for U.S. distribution by Viona Pharmaceuticals Inc.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

To date, neither Viona Pharmaceuticals nor Cadila Healthcare Limited have received any reports of adverse events related to this recall.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: The product is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus.

RECOMMENDATIONS:

Patients who have received impacted lots of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment.
Viona Pharmaceuticals is notifying its customers by email and mail (FedEx Overnight) and is arranging for the return of all recalled products.

Consumers with questions regarding this recall can contact our recall processor.
Customers with medical-related questions, who wish to report an adverse event, or quality issues about the products being recalled should contact Viona Pharmaceuticals.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

Manage Subscriptions | Unsubscribe All | Help