Drug product
PANCRELIPASE DR Capsule, Rx only, Distributed by: AidaPak Service, LLC, NDC 42865010302
D-558-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 Capsules
- Official record key
drug-enforcement:D-558-2014
Official wording
Reason: Labeling: Label Mixup; PANCRELIPASE DR Capsule may be potentially mislabeled as MELATONIN, Tablet, 1 mg, NDC 35046000391, Pedigree: W003317, EXP: 6/18/2014; VERAPAMIL HCL, Tablet, 40 mg, NDC 00591040401, Pedigree: W003170, EXP: 6/13/2014.
Code information: PANCRELIPASE DR, Capsule has the following codes Pedigree: W003354, EXP: 6/19/2014; Pedigree: W003171, EXP: 6/13/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled