Recalls / Class II
Class IID-204-2013
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
- Affected lot / code info
- 387879A, Exp. 02/13; 429105A, Exp. 06/13; 474488A, Exp. 11/13; 491672A, Exp. 01/14; 529095A, Exp. 04/14
Why it was recalled
Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .
Recalling firm
- Firm
- Watson Laboratories Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 311 Bonnie Cir, N/A, Corona, California 92880-2882
Distribution
- Quantity
- 20,587 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-02-08
- FDA classified
- 2013-03-19
- Posted by FDA
- 2013-03-27
- Terminated
- 2014-01-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-204-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.