FDA-Drug2016-01-27Class II

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.

Freedom Pharmaceuticals Inc
Hazard

Presence of Foreign Substance

Sold states
Nationwide
Affected count
(a) 6 containers, (b) 42 containers, (c) 31 containers, (d) 253 containers
Manufactured in
801 W New Orleans St, N/A, Broken Arrow, OK, United States
Products
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.

Official notice

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

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