December 2013 FDA Recall Drug by Watson Laboratories Inc
D-397-2014 - Presence of Foreign Substance; metal particulates were visually observed in the tablets.

This Class II drug recall was voluntarily initiated by Watson Laboratories Inc on December 23, 2013 for the product Drug. The FDA reported the reason for recall as presence of foreign substance; metal particulates were visually observed in the tablets.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-397-2014

Reason for Recall
Presence of Foreign Substance; metal particulates were visually observed in the tablets.
Initiated
12-23-2013
Reported
01-15-2014
Quantity
4,439 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67200
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.
Watson Laboratories 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-04-2014
Product Description About Product Description
Full technical description of the product.
Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured by Watson Pharma Private Ltd, Verna, Salcette, Goa, 403 722 INDIA. Distributed by: Watson Pharma Ltd, Parsippany, NJ 07054. NDC 0591-5513-05.

Batch or Lot Expiration Information

Lot# 244152A, exp 01/15.