Viona Pharmaceuticals Inc., Issuing Nationwide Voluntary Recall of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, Due to Detection of N-Nitrosodimethylamine (NDMA) Impurities

Summary

Company announcement

FOR IMMEDIATE RELEASE – 12/28/2021 – Cranford, New Jersey, Viona Pharmaceuticals Inc., reminds voluntarily thirty-three (33) a lot of Metformin Hydrochloride Sustained Release Tablets, USP 750 mg to the level of detail. The reason for the recall is an out-of-specification result observed for said product, lot number M008132, “N-nitrosodimethylamine (NDMA) (By GC-MS / MS)” test at 17 months, 25 ° C / 60% RH Stability samples long-term. As a precaution, the company is voluntarily recalling all 33 lots marketed with a valid shelf life. This product was manufactured by Cadila Healthcare Limited, Ahmedabad, India for distribution in the United States by Viona Pharmaceuticals Inc.

Risk statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on the results of laboratory tests. NDMA is a known environmental contaminant found in water and foods, including meats, dairy products, and vegetables. Patients who have received the affected lots of Metformin Hydrochloride Prolonged-Release Tablets, USP 750 mg are advised to continue to take their medicine and to contact their doctor for advice on alternative therapy. According to the FDA, it could be dangerous for patients with this serious illness to stop taking their metformin without first talking to their healthcare professionals. Please visit the agency’s website for more information at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma- metformin. To date, neither Viona Pharmaceuticals Inc. nor Cadila Healthcare Limited has received any adverse event reports related to this recall.

The product is used in addition to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus and is packaged in HDPE bottles of 100 tablets, under NDC 72578-036-01. Firm recalled Metformin Hydrochloride Sustained Release Tablets, USP 750 mg are listed in the table below. The product can be identified as White to off-white, capsule shaped, uncoated tablets debossed with “Z”, “C” on one side and “20” on the other side. Metformin Hydrochloride Sustained Release Tablets, USP 750 mg has been distributed Nationwide to distributors.

Viona Pharmaceuticals Inc., notify his clients through e-mail and courier (FedEx Overnight) and arrange for the return of all recalled products to our recall processor at the following address

Eversana Life Sciences Services
c / o Viona reminder
ATTN: Returns Department
4580 S. Mendenhall Road
Memphis, TN 38141

Consumers with questions regarding this recall can contact our recall processor. Eversana Life Science Services by phone at 1-888-304-5022, Option 1; Monday to Friday, 8:00 a.m. to 7:00 p.m. CDT. Consumers should contact their doctor or health care provider if they have had any problems that may be related to taking or using this medication.

Customers with medical questions, who wish to report an adverse event or quality concerns with the recalled products should contact Viona Pharmaceuticals Inc., by phone at: 888-304-5011Monday to Friday, 8:30 a.m. to 5:30 p.m. EST.

Adverse reactions or quality issues encountered while using this product can be reported to the MedWatch Adverse Event Reporting Program of the FDA, either online, by regular mail, or by fax.

• Complete and submit the report online
• Regular Mail or Fax: Download the form or call 1-800-332-1088 to request a report form, then complete and return it to the address on the pre-addressed form, or fax it to 1-800-FDA-0178

This recall is being made with the knowledge of the United States Food and Drug Administration.