US Drug Recall Register
Class II · Moderate risk Terminated Initiated Dec 23, 2013 (13 years ago)

Carisoprodol Tablets

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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.

Recalling firm
Watson Laboratories Inc
NDC code
0591-5513-05
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-397-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Carisoprodol recalls

See all
Class III · Low risk Terminated

Carisoprodol Tablets

Reason Failed Impurity/degradation Specification

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-819-20 D-1155-2014
Class II · Moderate risk Terminated

Carisoprodol IV

Reason Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing.

Physicians Total Care, Inc. D-390-2014
Class II · Moderate risk Terminated

Carisoprodol Tablets

Reason Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing

West-Ward Pharmaceutical Corp. NDC 0143-9749-10 D-367-2014
Class II · Moderate risk Terminated

Carisoprodol Tablets

Reason Presence of Foreign Substance: Uncharacteristic blacks spots on tablets.

West-ward Pharmaceutical Corp. NDC 0143-1176-05 D-150-2013
Class III · Low risk Terminated

Carisoprodol Tablets

Reason 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.

West-ward Pharmaceutical Corp. NDC 0143-1176-01 D-201-2013