Drug product
hydrALAZINE HCl Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111032801
D-591-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-591-2014
Official wording
Reason: Labeling: Label Mixup; hydrALAZINE HCl Tablet, 50 mg may be potentially mislabeled as CapsuleTOPRIL, Tablet, 12.5 mg, NDC 00143117101, Pedigree: AD52778_16, EXP: 5/20/2014.
Code information: hydrALAZINE HCl, Tablet, 50 mg has the following code Pedigree: AD52778_28, EXP: 5/20/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled