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. Maharasht

FDA recall notice · announced January 22, 2014 · Betachem

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: MO
Lot/code information: Lot #: DMFH-366/11, DMFH-367/11, DMFH-368/11, DMFH-369/11, DMFH-370/11, DMFH-371/11, DMFH-372/11, DMFH-373/11, DMFH-374/11, DMFH-375/11, DMFH-376/11, DMFH-393/11, DMFH-394/11, DMFH-395/11, DMFH-396/11, DMFH-397/11, DMFH-399/11, DMFH-400/11, DMFH-401/11, DMFH-402/11, DMFH-403/11, DMFH-404/11, DMFH-405/11, DMFH-406/11
Quantity: 27,000 kilos (1080 drums)
Status: Terminated
Products in this recall event:
- 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 (D-406-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.