Class III · Low risk
Carisoprodol Tablets
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.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
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.
Affected NDC
0143-1176-01
Compare with the code on your package — it is the most precise check available.
Drug: Carisoprodol
- 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 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Carisoprodol recalls
See all
Class II · Moderate risk
Carisoprodol Tablets
Presence of Foreign Substance; metal particulates were visually observed in the tablets.
Class II · Moderate risk
Carisoprodol IV
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
Carisoprodol Tablets
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
Carisoprodol Tablets
Presence of Foreign Substance: Uncharacteristic blacks spots on tablets.
Other recalls by West-ward Pharmaceutical Corp.
All 2012 recalls
Class II · Moderate risk
PredniSONE Tablets USP
Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.
Class III · Low risk
Fentanyl Citrate Inj.
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Class III · Low risk
Fentanyl Citrate Inj.
Failed Impurities/Degradation Specifications; 12 month stability testing.
Class II · Moderate risk
VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets
Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.
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