Class III · Low risk Terminated
Carisoprodol Tablets
Reason Failed Impurity/degradation Specification
Carisoprodol Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was 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.
What 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.
- Recalling firm
- West-ward Pharmaceutical Corp.
- NDC code
- 0143-1176-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-201-2013
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 II · Moderate risk Terminated
Carisoprodol Tablets
Reason Presence of Foreign Substance; metal particulates were visually observed in the tablets.
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.
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
Class II · Moderate risk Terminated
Carisoprodol Tablets
Reason Presence of Foreign Substance: Uncharacteristic blacks spots on tablets.
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