Drug product
MODAFINIL, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603466216.
D-986-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 Tablets
- Official record key
drug-enforcement:D-986-2014
Official wording
Reason: Labeling: Label Mixup: MODAFINIL, Tablet, 200 mg may have potentially been mislabeled as one of the following drugs: OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, NDC 00173078302, Pedigree: W003692, EXP: 6/26/2014.
Code information: MODAFINIL, Tablet, 200 mg has the following codes: Pedigree: W002760, EXP: 6/6/2014; Pedigree: W003779, EXP: 6/26/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled