Drug product
MELATONIN Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 35046000391
D-547-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 Tablets
- Official record key
drug-enforcement:D-547-2014
Official wording
Reason: Labeling: Label Mixup; MELATONIN Tablet, 1 mg may be potentially mislabeled as CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: W002692, EXP: 6/5/2014; GLYCOPYRROLATE, Tablet, 2 mg, NDC 00603318121, Pedigree: W003252, EXP: 6/17/2014.
Code information: MELATONIN Tablet, 1 mg has the following codes Pedigree: W002695, EXP: 6/5/2014; Pedigree: W003317, EXP: 6/18/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled