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Viona Pharmaceuticals recalls nearly 2 dozen lots of Metformin over NDMA concerns

Viona Pharmaceuticals has issued a recall of 23 lots of their 750 mg Metformin Hydrochloride Extended-Release Tablets. The recall was initiated after a routine test found 1 lot to be Out of Specification (OOS) for N-nitrosodimethylamine (NDMA). NDMA is considered a “probable human carcinogen”, meaning it could cause cancer. It’s been found in everything from water to foods such as: dairy, meat, and vegetables.

 

Recalled Products:

Batch Number: M008130   Exp. Date: 06/2022  

Batch Number: M008131   Exp. Date: 06/2022

Batch Number: M008132   Exp. Date: 06/2022

Batch Number: M008133   Exp. Date: 06/2022

Batch Number: M010080   Exp. Date: 07/2022

Batch Number: M010081   Exp. Date: 07/2022

Batch Number: M011029   Exp. Date: 08/2022

Batch Number: M011030   Exp. Date: 08/2022

Batch Number: M011031   Exp. Date: 08/2022

Batch Number: M011032   Exp. Date: 08/2022

Batch Number: M011304   Exp. Date: 08/2022

Batch Number: M013394   Exp. Date: 09/2022

Batch Number: M013395   Exp. Date: 09/2022

Batch Number: M013396   Exp. Date: 09/2022

Batch Number: M013966   Exp. Date: 09/2022

Batch Number: M013967   Exp. Date: 09/2022

Batch Number: M100831   Exp. Date: 12/2022

Batch Number: M100832   Exp. Date: 12/2022

Batch Number: M100833   Exp. Date: 01/2023

Batch Number: M100834   Exp. Date: 01/2023

Batch Number: M101267   Exp. Date: 01/2023

Batch Number: M102718   Exp. Date: 01/2023

Batch Number: M102719   Exp. Date: 01/2023

 

The official name and NDC are as follows: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg - NDC: 72578-036-01. They were distributed to retailers nationwide and packaged in HDPE bottles with 100 tablets. The tablets are “white to off-white” and have a “Z”  or “C” on one side and a “20” on the other side. The recalled products were manufactured in India, and still have a “valid” shelf life. At this time, consumers should continue taking these medications as prescribed, but should consult their doctor.

For information on this recall, click here: https://bit.ly/33COWnp