FDAClass IIMarch 27, 2013

Meprobamate recall: Impurity Out of Spec

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

Why was Meprobamate recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
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
Recalling firm
Watson Laboratories Inc
Quantity
20,587 bottles
Distribution
Nationwide and Puerto Rico
Recall date
March 27, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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