Drug product
LACTOBACILLUS GG Capsule, 10 Billion Cells, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49100036374
D-580-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 300 Cells
- Official record key
drug-enforcement:D-580-2014
Official wording
Reason: Labeling: Label Mixup; LACTOBACILLUS GG Capsule, 10 Billion Cells may be potentially mislabeled as guaiFENesin ER, Tablet, 600 mg, NDC 63824000815, Pedigree: AD21965_22, EXP: 5/1/2014.
Code information: LACTOBACILLUS GG, Capsule, 10 Billion Cells has the following code Pedigree: AD21965_19, EXP: 5/1/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled