PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: January 27, 2016 Initiated: November 9, 2015 #D-0573-2016

Product Description

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

Details

Units Affected
(a) 6 containers, (b) 42 containers, (c) 31 containers, (d) 253 containers
Distribution
Nationwide
Location
Broken Arrow, OK

Frequently Asked Questions

What product was recalled?
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.. Recalled by Freedom Pharmaceuticals Inc. Units affected: (a) 6 containers, (b) 42 containers, (c) 31 containers, (d) 253 containers.
Why was this product recalled?
Presence of Foreign Substance
Which agency issued this recall?
This recall was issued by the FDA Drug on January 27, 2016. Severity: Moderate. Recall number: D-0573-2016.