Drug product
LACTOBACILLUS ACIDOPHILUS, Tablet, 35 MILLION, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536718101.
D-946-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-946-2014
Official wording
Reason: Labeling: Label Mixup: LACTOBACILLUS ACIDOPHILUS, Tablet, 35 MILLION may have potentially been mislabeled as the following drug: REPAGLINIDE, Tablet, 1 mg, NDC 00169008281, Pedigree: W003924, EXP: 6/28/2014.
Code information: LACTOBACILLUS ACIDOPHILUS, Tablet, 35 MILLION has the following codes: Pedigree: W003865, EXP: 6/27/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled