Drug product
LACTOBACILLUS ACIDOPHILUS Capsule, 500 Million CFU, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 43292050022
D-560-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 700 Capsules
- Official record key
drug-enforcement:D-560-2014
Official wording
Reason: Labeling: Label Mixup; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 Million CFU may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: AD46257_56, EXP: 5/15/2014; MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: AD30028_28, EXP: 5/7/2014; CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: AD60240_11, EXP: 5/22/2014.
Code information: LACTOBACILLUS ACIDOPHILUS Capsule, 500 Million CFU has the following codes Pedigree: AD46257_28, EXP: 5/15/2014; Pedigree: AD30028_10, EXP: 5/7/2014; Pedigree: AD60240_20, EXP: 5/22/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled