Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured by Watson Pharma ...
FDA Recall #D-397-2014 — Class II — December 23, 2013
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.
Recalling Firm
Watson Laboratories Inc — Corona, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
4,439 bottles
Distribution
Nationwide
Code Information
Lot # 244152A, exp 01/15.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated