FDA recall D-0573-2016

Product

Baclofen USP powder, packaged in (a) 25gm (4 oz container), (b) 100gm (16 oz container), (c) 500 gm (70 oz container), and (d) 1000 gm (120 oz container, Rx only, 801 W New Orleans St. Broken Arrow, OK 74011. NDC: (a) 52372-0909-25; (b) 52372-0909-01; (c) 52372-0909-50; (d) 52372-0909-10.

Reason for recall

Presence of Foreign Substance

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-11-09

Report date

2016-01-27

Termination date

2016-12-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Broken Arrow, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0573-2016