As of 01/07/2022, Viona Pharmaceuticals Inc., located in Cranford, New Jersey, began to voluntarily recall 23 lots of Metformin HCI Extended- Release Tablets (USP 750 mg) due to an NDMA impurity. This was determined after an Out of Specification (OOS) test on batch M008132 found traces of NDMA.
NDMA is classified as a “probable human carcinogen”, or a substance that could cause cancer. NDMA is a known environmental contaminant and can be found in water and foods like meat, dairy products, and vegetables.
Metformin is used as an adjunct to diet and exercise to improve blood glucose in adults with type 2 diabetes. The products themselves can be identified as white/off-white, capsule shaped, uncoated tablets with the letter “Z”, “C” on one side and “20” on the other.
Those who are using Metformin Hydrochloride Extended-Release Tablets, USP 750 mg are to continue taking their medication and contact their physician regarding an alternative treatment. It could be dangerous for patients to stop taking their Metformin without first talking to their healthcare professionals, according to the FDA.
Fortunately, neither Viona Pharmaceuticals Inc nor Cadila Healthcare Limited (manufacturer) have received reports of adverse events related to the recall or the medicine.
Below, we have listed the recalled lots of Metformin HCI Extended-Release Tablets, USP 750 mg which were distributed nationwide to various distributors.
|Sr. Number||Batch Number||Expiration Date|
Viona Pharmaceuticals Inc., are letting consumers know about the recall via email and mail as well as arranging for the return of the recalled products to the following address:
Inmar Pharmaceuticals Services-Recalls
3845 Grand Lakes Way,
Grand Prairie, Texas 75050.
For more information, please visit the following link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/viona-pharmaceuticals-inc-issues-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets-0
If you or someone you know has been affected by the harmful impurities that could be found in Metformin, please do not hesitate to contact Boesen Law, LLC at (303) 999-9999 or visit our website at https://www.boesenlaw.com for more information.