Drug product
hydrALAZINE HCl Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155000401
D-526-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 400 Tablets
- Official record key
drug-enforcement:D-526-2014
Official wording
Reason: Labeling: Label Mixup; hydrALAZINE HCl Tablet, 100 mg may be potentially mislabeled as DOXEPIN HCL, Capsule, 150 mg, NDC 49884022201, Pedigree: AD46312_10, EXP: 5/16/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD73652_1, EXP: 5/29/2014; LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00378181101, Pedigree: AD30197_13, EXP: 5/9/2014.
Code information: hydrALAZINE HCl Tablet, 100 mg has the following codes Pedigree: AD46312_13, EXP: 5/16/2014; Pedigree: AD73652_4, EXP: 5/29/2014; Pedigree: AD30197_7, EXP: 5/9/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled