Recalls / Class II
Class IID-397-2014
Product
Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured by Watson Pharma Private Ltd, Verna, Salcette, Goa, 403 722 INDIA. Distributed by: Watson Pharma Ltd, Parsippany, NJ 07054. NDC 0591-5513-05.
- Affected lot / code info
- Lot # 244152A, exp 01/15.
Why it was recalled
Presence of Foreign Substance; metal particulates were visually observed in the tablets.
Recalling firm
- Firm
- Watson Laboratories Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 132 Business Center Dr, Corona, California 92880-1724
Distribution
- Quantity
- 4,439 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-12-23
- FDA classified
- 2014-01-06
- Posted by FDA
- 2014-01-15
- Terminated
- 2014-08-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-397-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.