January 2014 FDA Recall Metformin Hydrochloride by Caraco Pharmaceutical Laboratories, Ltd.
D-1089-2014 - Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER

This Class II drug recall was voluntarily initiated by Caraco Pharmaceutical Laboratories, Ltd. on January 28, 2014 for the product Metformin Hydrochloride. The FDA reported the reason for recall as presence of foreign tablet; customer complaint of some tablets of gabapentin found in a bottle of metformin hcl er. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1089-2014

Reason for Recall
Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER
Initiated
01-28-2014
Reported
03-05-2014
Quantity
2528 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67433
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.
Caraco Pharmaceutical Laboratories, Ltd.
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2014
Product Description About Product Description
Full technical description of the product.
Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc. Ltd, Andheri (East) Mumbai-400 059, India, Distributed by: Caraco Pharmaceutical Laboratories, Ltd, Detroit, MI --- NDC 62756-142-02

Batch or Lot Expiration Information

Batch# Batch JKM2433A, Mfg Date 04/2013; Exp 03/2016

Affected Packages Involved in this Recall

62756-142-01 Metformin Hydrochloride
62756-142-02 Metformin Hydrochloride
62756-143-01 Metformin Hydrochloride