Drug product
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
D-0937-2017
Product summary
- Event
- Event 77392
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,000g (5 kg)
- Official record key
drug-enforcement:D-0937-2017
Official wording
Reason: CGMP Deviations: Lack of quality assurance at the API manufacturer.
Code information: Lots: MCMR1308029NS, MCMR1308029NS-4202015; Exp. 08/18
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations