Drug product
CHOLECALCIFEROL, Capsule, 2000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536379001.
D-937-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18,282 Tablets
- Official record key
drug-enforcement:D-937-2014
Official wording
Reason: Labeling: Label Mixup: CHOLECALCIFEROL, Capsule, 2000 units may have potentially been mislabeled as one of the following drugs: DOXYCYCLINE HYCLATE, Tablet, 100 mg, NDC 53489012002, Pedigree: AD30993_8, EXP: 5/9/2014; VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 50 mg, NDC 40985022251, Pedigree: AD60211_20, EXP: 5/21/2014; lamoTRIgine, Tablet, 50 mg (1/2 of 100 mg), NDC 13668004701, Pedigree: A
Code information: CHOLECALCIFEROL, Capsule, 2000 units has the following codes: Pedigree: AD30028_7, EXP: 5/8/2014; Pedigree: AD60240_4, EXP: 5/22/2014; Pedigree: ADWA00002136, EXP: 5/31/2014; Pedigree: W002666, EXP: 6/5/2014; Pedigree: W003016, EXP: 6/12/2014; Pedigree: W003017, EXP: 6/12/2014; Pedigree: W003712, EXP: 6/26/2014; Pedigree: W003713, EXP: 6/26/2014; Pedigree: W003828, EXP: 6/27/2014; Pedigree: AD21846_4, EXP: 5/1/2014; Pedigree: AD46257_7, EXP: 5/15/2014; Pedigree: AD73521_7, EXP: 5/30/2014; Pedigree: W002691, EXP: 6/5/2014; Pedigree: W003314, EXP: 6/18/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled