Drug product
CapsuleTOPRIL, Tablet, 12.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00143117101.
D-863-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-863-2014
Official wording
Reason: Labeling: Label Mixup: CapsuleTOPRIL, Tablet, 12.5 mg may have potentially been mislabeled as the following drug:, CALCITRIOL, Capsule, 0.25 mcg, NDC 00054000725, Pedigree: AD52778_13, EXP: 5/20/2014.
Code information: CapsuleTOPRIL, Tablet, 12.5 mg has the following codes: Pedigree: AD52778_16, EXP: 5/20/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled