Drug 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.
D-397-2014
Product summary
- Event
- Event 67200
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,439 bottles
- Official record key
drug-enforcement:D-397-2014
Official wording
Reason: Presence of Foreign Substance; metal particulates were visually observed in the tablets.
Code information: Lot # 244152A, exp 01/15.
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance