Drug product
PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, Rx only, Distributed by: AidaPak Service, LLC, NDC 00032121207.
D-784-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 months
- Official record key
drug-enforcement:D-784-2014
Official wording
Reason: Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units may be potentially mislabeled as the following drug: ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg, NDC 00597000160, Pedigree: AD70639_4, EXP: 7/28/2013.
Code information: PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units has the following codes: Pedigree: AD70639_7, EXP: 5/29/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled