Drug product
LACTOBACILLUS ACIDOPHILUS Capsule, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 54629011101
D-618-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,392 Capsules
- Official record key
drug-enforcement:D-618-2014
Official wording
Reason: Labeling:Label Mixup; LACTOBACILLUS ACIDOPHILUS Capsule may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: AD65311_1, EXP: 5/24/2014; PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401, Pedigree: AD65457_4, EXP: 5/24/2014.
Code information: LACTOBACILLUS ACIDOPHILUS, Capsule has the following codes Pedigree: AD65311_7, EXP: 5/24/2014; Pedigree: AD65311_4, EXP: 5/24/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled