Drug product
PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, Rx only, Distributed by: AidaPak Service, LLC, NDC 00032121201.
D-783-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 400 Capsules
- Official record key
drug-enforcement:D-783-2014
Official wording
Reason: Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units may be potentially mislabeled as one of the following drugs: ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: W003726, EXP: 6/26/2014; LANTHANUM CARBONATE, CHEW Tablet, 500 mg, NDC 54092025290, Pedigree: W002790, EXP: 6/6/2014; CITALOPRAM, Tablet, 10 mg, NDC 57664050788, Pedigree: W002844, EXP: 6/7/2014; AT
Code information: PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units has the following codes: Pedigree: W003731, EXP: 6/26/2014; Pedigree: W002819, EXP: 6/7/2014; Pedigree: W002849; EXP: 6/7/2014; Pedigree: AD30180_4, EXP: 5/8/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled