Drug product
CAFFEINE Tablet, 200 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 24385060173
D-540-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 128 Tablets
- Official record key
drug-enforcement:D-540-2014
Official wording
Reason: Labeling: Label Mixup; CAFFEINE Tablet, 200 mg may be potentially mislabeled as CALCIUM CITRATE, Tablet, 950 mg (200 mg ELEMENTAL Ca), NDC 00904506260, Pedigree: AD21846_24, EXP: 5/1/2014; CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: AD60240_4, EXP: 5/22/2014; FEXOFENADINE HCL, Tablet, 60 mg, NDC 45802042578, Pedigree: W003020, EXP: 6/12/2014; MELATONIN, Tablet, 3 mg, ND
Code information: CAFFEINE Tablet, 200 mg has the following codes Pedigree: AD21846_37, EXP: 5/1/2014; Pedigree: AD60240_42, EXP: 5/22/2014; Pedigree: W003024, EXP: 6/12/2014; Pedigree: W003725, EXP: 6/26/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled