Drug product
DUTASTERIDE, Capsule, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00173071215.
D-873-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 Capsules
- Official record key
drug-enforcement:D-873-2014
Official wording
Reason: Labeling: Label Mixup: DUTASTERIDE, Capsule, 0.5 mg may have potentially been mislabeled as one of the following drugs: PHENOL, LOZENGE, 29 mg, NDC 00068021918, Pedigree: AD49582_13, EXP: 5/16/2014; REPAGLINIDE, Tablet, 2 mg, NDC 00169008481, Pedigree: AD70639_13, EXP: 5/29/2014; CHOLECALCIFEROL, Capsule, 5000 units, NDC 00904598660, Pedigree: AD52993_22, EXP: 5/20/2014.
Code information: DUTASTERIDE, Capsule, 0.5 mg has the following codes: Pedigree: AD49610_1, EXP: 5/16/2014; Pedigree: AD70633_1, EXP: 5/29/2014; Pedigree: AD52778_4, EXP: 5/20/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled