Viona Pharma recalls 21,240 bottles of this Diabetes drug

The voluntary ongoing nationwide recall in the US is a class-II recall, it added.

Picture: Pixabay

Last Updated on July 7, 2021 by The Health Master

Viona Pharmaceuticals Inc is recalling over 21,000 bottles of metformin hydrochloride extended-release tablets manufactured by Ahemdabad-based Cadila Healthcare, the latest enforcement report of the US Food and Drug Administration (USFDA) said.

Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus.

Viona Pharmaceuticals Inc is recalling 21,240 bottles of metformin hydrochloride extended-release tablets, USP 750 mg, on account of “CGMP Deviations: FDA analysis detected n-nitrosodimethylamine (NDMA) levels in excess of the acceptable daily intake limit”, the report by the US health regulator said.

The voluntary ongoing nationwide recall in the US is a class-II recall, it added.

As per USFDA, a class-II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

NDMA is classified as a probable human carcinogen based on results from laboratory tests. It is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.

Viona Pharmaceuticals Inc is a wholly-owned indirect subsidiary of Cadila Healthcare.

Dr Reddy’s recalls 2,980 bottles of Atorvastatin Calcium tablets

Sun Pharma recalls 50,868 bottles of diabetes drug in US

Lupin, Sun, Jubilant recall generic medicines in US

Sun Pharma, Alembic recall products in the US market

Zydus Cadila, Alembic Pharma recall these 2 drugs in US

Pharma Companies recall these drugs in US

Procedure to obtain License to Manufacture drugs for testing and analysis…

9 arrested over supplying spurious drugs remanded in Police custody

Oral dose for COVID from Indian Drug maker soon

This Hospital to offer free plastic surgery

Neurological disorder: Treat Kids without delay: Doctors

Germany recommends mixing of these vaccines

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon
YouTube Icon

Enter your email address:

Delivered by FeedBurner