Posted on 12/29/2021 10:34:24 PM PST by blueplum
FOR IMMEDIATE RELEASE – 12/28/2021 – Cranford, New Jersey, Viona Pharmaceuticals Inc., is voluntarily recalling thirty three (33) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg to the retail level. Reason for the recall is an Out of specification result observed for the said product, Lot number M008132, “N-nitrosodimethylamine (NDMA) (By GC-MS/MS)” test at 17 Month(s), 25°C/60%RH Long-term stability samples. As a precautionary measure firm voluntarily recall all the marketed 33 batches having valid shelf life. This product was manufactured by Cadila Healthcare Limited, Ahmedabad, India 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. To date, neither Viona Pharmaceuticals Inc., nor Cadila Healthcare Limited have received any reports of adverse events related to this recall.
The product is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in HDPE bottles of 100 tablets....
[lot numbers at link]
(Excerpt) Read more at fda.gov ...
Whoa. I take metformin. 1000 mg. x2 daily. Have for years. But I’m a pharmacological ignoramus - I never look at the inserts, I just put it with all my other meds and take what the doc tells me. Any other way of determining where mine came from?
I take the same.
It sounds like only extended release Metformin is affected, so I believe we are safe. Your prescription would say “Metformin ER” if it was Extended Release.
I think people usually take Metformin Extended Release once a day.
Ah, got it. Mine aren’t then, if I have to take an evening dose. I keep an extra bottle here with me in the den so I don’t forget the second one, and I don’t see any ER on the label. Thanks.
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