Baclofen USP powder, packaged in (a) 25gm (4 oz container), (b) 100gm (16 oz container), (c) 50...
FDA Recall #D-0573-2016 — Class II — November 9, 2015
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
Recalling Firm
Freedom Pharmaceuticals Inc — Broken Arrow, OK
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
(a) 6 containers, (b) 42 containers, (c) 31 containers, (d) 253 containers
Distribution
Nationwide
Code Information
Lot #: F10918, F10918-2, Exp: 07/24/2016; F10867, F10867A, Exp date: 03/11/2016
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated