Class II · Moderate risk Ongoing
Methocarbamol Injection USP 1
Reason Lack of Assurance of Sterility: Media fill with bacterial contamination
Methocarbamol
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Lack of quality assurance at the API manufacturer.
What was recalled
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
- Recalling firm
- American Pharmaceutical Ingredients LLC
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0937-2017
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 Methocarbamol recalls
See all
Class I · High risk Ongoing
Methocarbamol Injection
Reason Presence of Particulate Matter
Class I · High risk Completed
Methocarbamol 500mg Tablet
Reason Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
Class II · Moderate risk Terminated
Methocarbamol 500mg 500
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Methocarbamol liquid 100mg/ml
Reason Lack of sterility assurance.
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