D-397-2014 Class II Terminated
FDA drug recall D-397-2014 was initiated by Watson Laboratories Inc on December 23, 2013 and is designated Class II. Reason for recall: Presence of Foreign Substance; metal particulates were visually observed in the tablets. The recall status is terminated (terminated August 4, 2014). Affected quantity: 4,439 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 15, 2014
- Initiation Date
- December 23, 2013
- Termination Date
- August 4, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,439 bottles
Product Description
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.
Distribution Pattern
Nationwide
Code Information
Lot # 244152A, exp 01/15.