Drug product
OMEGA-3 FATTY ACID, Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 05445800022
D-496-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 Capsules
- Official record key
drug-enforcement:D-496-2014
Official wording
Reason: Labeling: Label Mixup; OMEGA-3 FATTY ACID, Capsule, 1000 mg may be potentially mislabeled as NORTRIPTYLINE HCL, Capsule, 50 mg, NDC 00093081201, Pedigree: AD21790_70, EXP: 5/1/2014.
Code information: OMEGA-3 FATTY ACID, Capsule, 1000 mg has the following code Pedigree: AD21858_4, EXP: 5/1/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled