Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only, Manufactured…
Reason Failed Impurity/degradation Specification
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Presence of Foreign Substance: Uncharacteristic blacks spots on tablets.
Carisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottle (NDC 0143-1176-05) and b) 1000-count tablets per bottle (NDC 0143-1176-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.
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.
Reason Failed Impurity/degradation Specification
Reason Presence of Foreign Substance; metal particulates were visually observed in the tablets.
Reason Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine…
Reason Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine…
Reason Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Register making this product a schedule IV…
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