Drug Enforcement D-397-2014

Presence of Foreign Substance; metal particulates were visually observed in the tablets.

Status

Terminated

Classification

Class II

Report Date

January 15, 2014

Termination Date

August 4, 2014

Product Information

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.
Product quantity
4,439 bottles
Reason for recall
Presence of Foreign Substance; metal particulates were visually observed in the tablets.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Watson Laboratories Inc
Address
132 Business Center Dr

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-397-2014
Event ID
67200
Recall initiation date
December 23, 2013
Center classification date
January 6, 2014
Code info
Lot # 244152A, exp 01/15.
More code info
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