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.
FDA recall notice · announced January 15, 2014 · Watson Laboratories
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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.
Reason for recall
Presence of Foreign Substance; metal particulates were visually observed in the tablets.
Notes
Distribution: Nationwide
Lot/code information: Lot # 244152A, exp 01/15.
Quantity: 4,439 bottles
Status: Terminated
Products in this recall event:
- 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 070 (D-397-2014)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.