Viona Pharmaceuticals Inc., Issues Voluntary Nationwide Recall of Metformin HCl Extended-Release Tablets, USP 750 mg, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

<!--[if (gte mso 9)|(IE)]>

<![endif]-->

<!--[if (gte mso 9)|(IE)]>

<![endif]-->

<!--[if (gte mso 9)|(IE)]>

<![endif]-->

<!--[if (gte mso 9)|(IE)]>

<![endif]--> <!--[if (gte mso 9)|(IE)]>

<![endif]-->

<!--[if (gte mso 9)|(IE)]>

<![endif]-->

Viona Pharmaceuticals Inc., Issues Voluntary Nationwide Recall of Metformin HCl Extended-Release Tablets, USP 750 mg, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

Viona Pharmaceuticals Inc., is voluntarily recalling 2 (two) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg to the retail level. The 2 (two) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg have been found to contain levels of Nitrosodimethylamine (NDMA) impurities above acceptable daily limits. This product was manufactured by Cadila Healthcare Limited, Ahmedabad, India in November 2019, for U.S. distribution by Viona Pharmaceuticals Inc.

Risk Statement: 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. 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. According to the FDA, it could be dangerous for patients with this serious condition 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.

<!--[if (gte mso 9)|(IE)]>

<![endif]-->

<!--[if (gte mso 9)|(IE)]>

<![endif]-->

<!--[if mso]>

<![endif]-->

Leave a Reply Cancel reply
Your email address will not be published. Required fields are marked *
Comment *
Name *

Email *

Website

Save my name, email, and website in this browser for the next time I comment.

Post navigation

Previous Post Purina Animal Nutrition Voluntarily Recalling One Lot of Purina® RangeLand® 30-13 (125#) Cattle Feed
Next Post Freshpet Voluntarily Recalls One Lot of Freshpet® Select Small Dog Bite Size Beef & Egg Recipe Dog Food Due to Potential Salmonella Contamination

Search for:

Recent Posts

Savencia Cheese USA Announces Voluntary Recall of Select Soft Ripened Cheeses

Boulla LLC Issues Voluntary Nationwide Recall of ZoomMax and ZapMax Capsules Due to the Presence of Undeclared Sildenafil and Diclofenac

Savencia Cheese USA Announces an Expanded Voluntary Recall of Select Soft Ripened Cheeses

HH Fresh Trading Corp Recalls Taiwan Enoki 200gx25pk Because of Possible Health Risk

FDA MedWatch – Compunded Drugs by Fullerton Wellness

Proudly powered by WordPress