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