Drug product
FLUoxetine HCl Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714035103
D-517-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Capsules
- Official record key
drug-enforcement:D-517-2014
Official wording
Reason: Labeling: Label Mixup; FLUoxetine HCl, Capsule, 10 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401, Pedigree: AD70585_10, EXP: 5/29/2014.
Code information: FLUoxetine HCl, Capsule, 10 mg has the following code Pedigree: AD70585_13, EXP: 5/29/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled