Drug product
WARFARIN SODIUM Tablet, 0.5 mg (1/2 of 1 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 51672402701
D-602-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 Tablets
- Official record key
drug-enforcement:D-602-2014
Official wording
Reason: Labeling: Label Mixup; WARFARIN SODIUM, Tablet, 0.5 mg (1/2 of 1 mg) may be potentially mislabeled as SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: AD70636_1, EXP: 5/29/2014.
Code information: WARFARIN SODIUM, Tablet, 0.5 mg (1/2 of 1 mg) has the following code Pedigree: AD60590_4, EXP: 5/29/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled