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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Product Detail

Product Description 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
Recall Number D-406-2014
Classification Class II
Code Info 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
Product Distributed Qty 27,000 kilos (1080 drums)
Reason For Recall CGMP Deviations: The Active Pharmaceutical Ingredient was not manufactured according to current good manufacturing practices.

Event Detail

Event Id 67155
Product Type Drugs
Status Ongoing
Recalling Firm Betachem, Inc.
City Upper Saddle River
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-07
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern MO