FDA Drug Class II — Moderate

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

Hazard

CGMP Deviations: Lack of quality assurance at the API manufacturer.

Products

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
Brand
American Pharmaceutical Ingredients LLC
UPC
Lots: MCMR1308029NS, MCMR1308029NS-4202015; Exp. 08/18

Units Affected

5,000g (5 kg)