D-204-2013 Class II Terminated

Recalled by Watson Laboratories Inc — Corona, CA

Recall Details

Product Type
Drugs
Report Date
March 27, 2013
Initiation Date
February 8, 2013
Termination Date
January 31, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20,587 bottles

Product Description

Meprobamate; Tablets USP, 400 mg, 100 tablets; Rx only; Manufactured By: Watson Laboratories, Inc., Corona, CA 92800 USA; 173266; . Distributed by: Watson Pharma, Inc., NDC 0591-5238-01

Reason for Recall

Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .

Distribution Pattern

Nationwide and Puerto Rico

Code Information

387879A, Exp. 02/13; 429105A, Exp. 06/13; 474488A, Exp. 11/13; 491672A, Exp. 01/14; 529095A, Exp. 04/14