FDAFDA · Food and drugs·Recall number D-0937-2017
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
Published July 12, 2017 · Recall initiated: May 26, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Lack of quality assurance at the API manufacturer.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Distributor
- Nationwide
- Lot
- Lots: MCMR1308029NS, MCMR1308029NS-4202015; Exp. 08/18
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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