FDA-Drug2020-07-22Class II
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
Granules Pharmaceuticals Inc
Hazard
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Sold states
US Nationwide
Affected count
a) 476,073 bottles; b) 2,100 bottles
Manufactured in
3701 Concorde Pkwy, N/A, Chantilly, VA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1386-2020Don't want to check this manually?
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