Drug Enforcement D-203-2013

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

Status

Terminated

Classification

Class II

Report Date

March 27, 2013

Termination Date

January 31, 2014

Product Information

Product description
Meprobamate, Tablets USP, 200 mg, 100 tablets; Rx only; Manufactured By: Watson Laboratories, Inc., Corona, CA 92800 USA; 173266; . Distributed by: Watson Pharma, Inc., NDC 9591-5239-01
Product quantity
9,824 bottles
Reason for recall
Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide and Puerto Rico

Location & Firm

Recalling firm
Watson Laboratories Inc
Address
311 Bonnie Cir, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-203-2013
Event ID
64312
Recall initiation date
February 8, 2013
Center classification date
March 19, 2013
Code info
386585A, Exp. 02/13; 429104A, Exp. 06/13; 474487A, Exp. 11/13; 491671A, Exp.01/14.
More code info
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