Drug product
LACTOBACILLUS ACIDOPHILUS Capsule, 500 Million CFU, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 43292055746
D-562-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 999 Capsules
- Official record key
drug-enforcement:D-562-2014
Official wording
Reason: Labeling: Label Mixup; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 Million CFU may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: W002694, EXP: 6/5/2014
Code information: LACTOBACILLUS ACIDOPHILUS, Capsule, 500 Million CFU has the following code Pedigree: W002698, EXP: 6/5/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled