Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Impurity/degradation Specification
Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL NDC 51079-819-20
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 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 Presence of Foreign Substance: Uncharacteristic blacks spots on 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…
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