FDA recall D-0937-2017

American Pharmaceutical Ingredients LLC · Class II · 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

Reason for recall

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

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2017-05-26
Report date: 2017-07-12
Termination date: 2018-05-31
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waterford, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0937-2017