Drug product
PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, Rx only, Distributed by: AidaPak Service, LLC, NDC 00032122401.
D-785-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 498 Capsules
- Official record key
drug-enforcement:D-785-2014
Official wording
Reason: Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units may be potentially mislabeled as one of the following drugs: SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: AD70585_7, EXP: 5/29/2014; THYROID, Tablet, 60 mg, NDC 00456045901, Pedigree: W002848, EXP: 6/7/2014; CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: W003744, EXP: 6/26/2014; amLOD
Code information: PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units has the following codes: Pedigree: AD70585_10, EXP: 5/29/2014 Pedigree: W002850, EXP: 6/7/2014; Pedigree: W003856, EXP: 6/26/2014 Pedigree: AD65457_4, EXP: 5/24/2014; Pedigree: AD70655_1, EXP: 5/28/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled