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 Ingredie

FDA recall notice · announced July 12, 2017 · American Pharmaceutical Ingredients

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

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

Notes

Distribution: Nationwide
Lot/code information: Lots: MCMR1308029NS, MCMR1308029NS-4202015; Exp. 08/18
Quantity: 5,000g (5 kg)
Status: Terminated
Products in this recall event:
- 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 un (D-0937-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.