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 .
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
Lot numbers, UPCs & expiration codes
387879A, Exp. 02/13; 429105A, Exp. 06/13; 474488A, Exp. 11/13; 491672A, Exp. 01/14; 529095A, Exp. 04/14
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-204-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 8, 2013
- FDA report date
- Mar 27, 2013
- Quantity
- 20,587 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Watson Laboratories Inc
Original FDA data
Every field from FDA enforcement report D-204-2013, exactly as published.
Show all FDA fields
- City
- Corona
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 64312
- Address
- 311 Bonnie Cir
- Code information
- 387879A, Exp. 02/13; 429105A, Exp. 06/13; 474488A, Exp. 11/13; 491672A, Exp. 01/14; 529095A, Exp. 04/14
- Postal code
- 92880-2882
- Report date
- Mar 27, 2013
- Product type
- Drugs
- Recall number
- D-204-2013
- Classification
- Class II
- Recalling firm
- Watson Laboratories Inc
- Product quantity
- 20,587 bottles
- Termination date
- Jan 31, 2014
- Reason for recall
- Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Feb 8, 2013
- Initial firm notification
- Letter
- Center classification date
- Mar 19, 2013