Drug product
HYDRALAZINE HCL Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111032701
D-590-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-590-2014
Official wording
Reason: Labeling: Label Mixup; HYDRALAZINE HCL Tablet, 25 mg may be potentially mislabeled as DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedigree: AD49582_16, EXP: 5/16/2014.
Code information: HYDRALAZINE HCL, Tablet, 25 mg has the following code Pedigree: AD49610_4, EXP: 5/16/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled