FDA recall D-406-2014

Betachem, Inc. · Class II · drug

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

Reason for recall

CGMP Deviations: The Active Pharmaceutical Ingredient was not manufactured according to current good manufacturing practices.

Distribution

Key facts

Status: Terminated
Initiation date: 2013-10-07
Report date: 2014-01-22
Termination date: 2017-08-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Upper Saddle River, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-406-2014