More metformin recalled due to nitrosamine impurity
The recall includes 33 lots of metformin hydrochloride extended-release tablets USP (750 mg) manufactured in India and distributed in the U.S.
The FDA on Dec. 28 announced another recall of metformin due to excess levels of N-nitrosodimethylamine (NDMA).
Viona Pharmaceuticals Inc. recalled an additional 33 lots of metformin hydrochloride extended-release tablets USP (750 mg) to the retail level due to levels of NDMA impurities above acceptable daily limits. The product was manufactured by Cadila Healthcare Limited in India for U.S. distribution by Viona Pharmaceuticals Inc. Affected products were distributed nationwide to distributors. No related adverse events have been reported.