Freedom Pharmaceuticals Inc recalls Baclofen USP powder, packaged in (a) 25gm (4 oz container), (b) 100gm (16 oz container), (c) 500 gm (70 oz container),…

Recall date

November 9, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0573-2016

FDA classification

Class II

Brand / firm

Freedom Pharmaceuticals Inc

Sold / distributed

Nationwide

Why it was recalled

Presence of Foreign Substance

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.