D-0573-2016 Class II Terminated
FDA drug recall D-0573-2016 was initiated by Freedom Pharmaceuticals Inc on November 9, 2015 and is designated Class II. Reason for recall: Presence of Foreign Substance The recall status is terminated (terminated December 23, 2016). Affected quantity: (a) 6 containers, (b) 42 containers, (c) 31 containers, (d) 253 containers.
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