Drug product
DOXYCYCLINE MONOHYDRATE Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49884072703
D-588-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 799 Capsules
- Official record key
drug-enforcement:D-588-2014
Official wording
Reason: Labeling: Label Mixup; DOXYCYCLINE MONOHYDRATE Capsule, 100 mg may be potentially mislabeled as diphenhydrAMINE HCl, Tablet, 25 mg, NDC 00904555159, Pedigree: AD67992_4, EXP: 5/28/2014; DUTASTERIDE, Capsule, 0.5 mg, NDC 00173071215, Pedigree: AD52778_4, EXP: 5/20/2014.
Code information: DOXYCYCLINE MONOHYDRATE, Capsule, 100 mg has the following codes Pedigree: AD65323_7, EXP: 5/28/2014; Pedigree: AD52778_25, EXP: 5/20/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled