PlainRecalls
FDA Drug Low Class III Terminated

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.

Reported: March 27, 2013 Initiated: November 30, 2012 #D-201-2013

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.

Details

Units Affected
1763 bottles
Distribution
Nationwide
Location
Eatontown, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by West-ward Pharmaceutical Corp.. Units affected: 1763 bottles.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 27, 2013. Severity: Low. Recall number: D-201-2013.