Drug product
CapsuleTOPRIL, Tablet, 6.25 mg (1/2 of 12.5 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 00143117101.
D-864-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 Tablets
- Official record key
drug-enforcement:D-864-2014
Official wording
Reason: Labeling: Label Mixup: CapsuleTOPRIL, Tablet, 6.25 mg (1/2 of 12.5 mg) may have potentially been mislabeled as the following drug:, LUBIPROSTONE, Capsule, 24 mcg, NDC 64764024060, Pedigree: AD46312_1, EXP: 5/16/2014.
Code information: CapsuleTOPRIL, Tablet, 6.25 mg (1/2 of 12.5 mg) has the following codes: Pedigree: AD46312_4, EXP: 5/16/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled