Betachem, Inc. recalls Metformin Hydrochloride USP, Active Pharmaceutical Ingredient for manufacturing, processing or re-packing use only, 25 k
Recalled January 22, 2014 · FDA recall D-406-2014 · Betachem
Hazard
CGMP Deviations: The Active Pharmaceutical Ingredient was not manufactured according to current good manufacturing practices. · FDA Class II
Units
27,000 kilos (1080 drums)
Sold at
MO
Description
CGMP Deviations: The Active Pharmaceutical Ingredient was not manufactured according to current good manufacturing practices.
Product
Metformin Hydrochloride USP, Active Pharmaceutical Ingredient for manufacturing, processing or re-packing use only, 25 kg drum, Rx only, Manufactured by: Smruthi Organics Limited, Plot No.: A-27 M.I.D.C., Chincholi, Taq.: Mohol, Solapur-413 255. Maharashtra, India; NDC No. 10828-002-06, Cas No: 1115-70-4
Manufacturer(s)
Betachem, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →