Drug product
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.
D-0573-2016
Product summary
- Event
- Event 72854
- Status
- Terminated
- Classification
- Class II
- Quantity
- (a) 6 containers, (b) 42 containers, (c) 31 containers, (d) 253 containers
- Official record key
drug-enforcement:D-0573-2016
Official wording
Reason: Presence of Foreign Substance
Code information: Lot #: F10918, F10918-2, Exp: 07/24/2016; F10867, F10867A, Exp date: 03/11/2016
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance