October 2013 FDA Recall Drug by Betachem, Inc.
D-406-2014 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Betachem, Inc. on October 7, 2013 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in MO and the recall is currently terminated.

Recall Number: D-406-2014

Reason for Recall
CGMP Deviations: The Active Pharmaceutical Ingredient was not manufactured according to current good manufacturing practices.
Initiated
10-07-2013
Reported
01-22-2014
Quantity
27,000 kilos (1080 drums)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67155
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Betachem, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MO
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-07-2017
Product Description About Product Description
Full technical description of 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

Batch or Lot Expiration 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