Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, Manufactured by: West...
FDA Recall #D-201-2013 — Class III — November 30, 2012
Product Description
Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724, NDC 0143-1176-01.
Reason for Recall
Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Register making this product a schedule IV (C-IV)controlled substance. This product is being recalled because this controlled product was not relabeled with the required "C-IV" imprint on the label for products distributed after the 06/11/12 deadline.
Recalling Firm
West-ward Pharmaceutical Corp. — Eatontown, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
1763 bottles
Distribution
Nationwide
Code Information
Lot #: 69160A
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated