Drug Enforcement D-406-2014

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

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

August 7, 2017

Product Information

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
Product quantity
27,000 kilos (1080 drums)
Reason for recall
CGMP Deviations: The Active Pharmaceutical Ingredient was not manufactured according to current good manufacturing practices.
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
MO

Location & Firm

Recalling firm
Betachem, Inc.
Address
58 Ware Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-406-2014
Event ID
67155
Recall initiation date
October 7, 2013
Center classification date
January 10, 2014
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
More code info
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