Drug product
MELATONIN, Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 74312002832
D-734-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 360 Tablets
- Official record key
drug-enforcement:D-734-2014
Official wording
Reason: Labeling:Label Mixup; MELATONIN, Tablet, 1 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: W003711, EXP: 6/26/2014.
Code information: MELATONIN, Tablet, 1 mg has the following code Pedigree: W003717, EXP: 6/26/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled