November 2012 FDA Recall Drug by Caraco Pharmaceutical Laboratories, Ltd.
D-089-2013 - Adulterated Presence of Foreign Tablets

This Class II drug recall was voluntarily initiated by Caraco Pharmaceutical Laboratories, Ltd. on November 5, 2012 for the product Drug. The FDA reported the reason for recall as adulterated presence of foreign tablets. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-089-2013

Reason for Recall
Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50 mg contained some tablets of Metoprolol Tartrate Tablets USP, 50 mg.
Initiated
11-05-2012
Reported
12-12-2012
Quantity
2,264 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63628
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-12-2013
Product Description About Product Description
Full technical description of the product.
traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufactured by: Sun Pharmaceuticals Industries, Dadra 396 191, India; Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; NDC 57664-377-18.

Batch or Lot Expiration Information

Lot# GKK1373, Exp 09/13