Drug product
MELATONIN, Tablet, 3 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 08770140813
D-497-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,710 Tablets
- Official record key
drug-enforcement:D-497-2014
Official wording
Reason: Labeling: Label Mixup; MELATONIN, Tablet, 3 mg may be potentially mislabeled as VITAMIN B COMPLEX, Capsule, NDC 00536478701, Pedigree: AD32757_4, EXP: 5/13/2014; MULTIVITAMIN/ MULTIMINERAL/ LUTEIN, Capsule, NDC 24208063210, Pedigree: W003025, EXP: 6/12/2014; LACTASE ENZYME, Tablet, 3000 units, NDC 24385014976, Pedigree: W003721, EXP: 6/26/2014; GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400
Code information: MELATONIN, Tablet, 3 mg has the following codes Pedigree: AD46257_56, EXP: 5/15/2014; Pedigree: W003022, EXP: 6/12/2014; Pedigree: W003723, EXP: 6/26/2014; Pedigree: AD21846_34, EXP: 5/1/2014; Pedigree: AD30028_28, EXP: 5/7/2014; Pedigree: AD60240_39, EXP: 5/22/2014; Pedigree: AD73521_31, EXP: 5/30/2014; Pedigree: W002701, EXP: 6/5/2014; Pedigree: W003320, EXP: 6/19/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled