Drug 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
D-204-2013
Product summary
- Event
- Event 64312
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20,587 bottles
- Official record key
drug-enforcement:D-204-2013
Official wording
Reason: Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .
Code information: 387879A, Exp. 02/13; 429105A, Exp. 06/13; 474488A, Exp. 11/13; 491672A, Exp. 01/14; 529095A, Exp. 04/14
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
out of specification