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D-0573-2016 Class II Terminated

Recalled by Freedom Pharmaceuticals Inc — Broken Arrow, OK

Recall Details

Product Type: Drugs
Report Date: January 27, 2016
Initiation Date: November 9, 2015
Termination Date: December 23, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: (a) 6 containers, (b) 42 containers, (c) 31 containers, (d) 253 containers

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

Distribution Pattern

Nationwide

Code Information

Lot #: F10918, F10918-2, Exp: 07/24/2016; F10867, F10867A, Exp date: 03/11/2016