Drug product
MELATONIN, Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 04746900466
D-494-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 359 Tablets
- Official record key
drug-enforcement:D-494-2014
Official wording
Reason: Labeling: Label Mixup; MELATONIN, Tablet, 1 mg may be potentially mislabeled as QUETIAPINE FUMARATE, Tablet, 12.5 MG (1/2 of 25 MG), NDC 47335090288, Pedigree: AD21790_79, EXP: 5/1/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD73521_13, EXP: 5/30/2014.
Code information: MELATONIN, Tablet, 1 mg has the following codes Pedigree: AD21846_17, EXP: 5/1/2014; Pedigree: AD73521_19, EXP: 5/30/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled