Drug product
CALCITRIOL Capsule, 0.5 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63304024001
D-676-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 500 Capsules
- Official record key
drug-enforcement:D-676-2014
Official wording
Reason: Labeling:Label Mixup; CALCITRIOL, Capsule, 0.5 mcg may be potentially mislabeled as NIACIN TR, Tablet, 250 mg, NDC 10939043533, Pedigree: W003756, EXP: 5/31/2014; ISONIAZID, Tablet, 300 mg, NDC 00555007102, Pedigree: AD32757_28, EXP: 5/13/2014.
Code information: CALCITRIOL, Capsule, 0.5 mcg has the following codes Pedigree: W003730, EXP: 6/26/2014; Pedigree: AD32757_10, EXP: 5/14/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled