Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Lack of quality assurance at the API manufacturer.
Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500 g container (NDC: 58597-8023-7), c) 1,000 g container (NDC: 58597-8023-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
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 Lack of Assurance of Sterility: Media fill with bacterial contamination
Reason Presence of Particulate Matter
Reason Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Lack of sterility assurance.
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