Drug product
CHOLECALCIFEROL, Tablet, 5000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00761017840.
D-996-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 604 Tablets
- Official record key
drug-enforcement:D-996-2014
Official wording
Reason: Labeling: Label Mixup: CHOLECALCIFEROL, Tablet, 5000 units may have potentially been mislabeled as one of the following drugs: LACTOBACILLUS ACIDOPHILUS, Capsule, 0 mg, NDC 54629011101, Pedigree: AD65311_7, EXP: 5/24/2014; QUINAPRIL HCL, Tablet, 20 mg, NDC 68180055809, Pedigree: W003556, EXP: 6/24/2014; POTASSIUM ACID PHOSPHATE, Tablet, 500 mg, NDC 00486111101, Pedigree: AD52778_34, EXP: 5/20/2
Code information: CHOLECALCIFEROL, Tablet, 5000 units has the following codes: Pedigree: AD65457_10, EXP: 5/24/2014; Pedigree: W003557, EXP: 6/24/2014; Pedigree: AD56917_10, EXP: 5/21/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled