Drug product
MELATONIN Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 47469000466
D-576-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 360 Tablets
- Official record key
drug-enforcement:D-576-2014
Official wording
Reason: Labeling: Label Mixup; MELATONIN, Tablet, 1 mg may be potentially mislabeled as hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: AD46265_28, EXP: 5/15/2014; GLUCOSAMINE/CHONDROITIN DS, Tablet, 500 mg/400 mg, NDC 00904559293, Pedigree: AD60211_17, EXP: 5/22/2014.
Code information: MELATONIN, Tablet, 1 mg has the following codes Pedigree: AD46257_19, EXP: 5/15/2014; Pedigree: AD60240_14, EXP: 5/22/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled