Drug product
MELATONIN Tablet, 3 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 51991001406
D-605-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 718 Tablets
- Official record key
drug-enforcement:D-605-2014
Official wording
Reason: Labeling: Label Mixup; MELATONIN Tablet, 3 mg may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD25452_13, EXP: 5/3/2014; PIOGLITAZONE, Tablet, 15 mg, NDC 00591320530, Pedigree: AD28322_4, EXP: 4/30/2014; COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: AD70655_11, EXP: 5/28/2014; COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree
Code information: MELATONIN, Tablet, 3 mg has the following codes Pedigree: AD25452_16, EXP: 5/3/2014; Pedigree: AD28322_7, EXP: 5/6/2014; Pedigree: AD70655_14, EXP: 5/28/2014; Pedigree: W003999, EXP: 7/1/2014; Pedigree: AD32325_7, EXP: 5/9/2014; Pedigree: AD68019_7, EXP: 5/28/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled