Granules Pharmaceuticals Inc recalls Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (N
Recalled July 22, 2020 · FDA recall D-1386-2020 · Granules Pharmaceuticals
Hazard
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level · FDA Class II
Units
a) 476,073 bottles; b) 2,100 bottles
Sold at
US Nationwide
Description
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Product
Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (NDC 70010-492-05), Manufactured for: Granules Pharmaceutical Inc., Chantilly, VA, Manufactured by: Granules India Limited, Hyderabad - 500-081, India
Manufacturer(s)
Granules Pharmaceuticals Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →