Reported Jan 22, 2014 · Terminated

Metformin Hydrochloride USP, Active Pharmaceutical Ingredient for manufacturing, processing or re-packing use only, 25…

Betachem, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Betachem, Inc. · 58 Ware Rd · Upper Saddle River, NJ · 07458-1922

Metformin Hydrochloride USP, Active Pharmaceutical Ingredient for manufacturing, processing or re-packing use only, 25 kg drum, Rx only
Manufactured bySmruthi Organics Limited, Plot No.: A-27 M.I.D.C., Chincholi, Taq.: Mohol, Solapur-413 255. Maharashtra, India; NDC No. 10828-002-06
Cas No1115-70-4

Lot codes and dates: 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
Amount recalled: 27,000 kilos (1080 drums)

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

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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