Drug product
LACTOBACILLUS GG Capsule, 15 Billion Cells, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49100036374
D-581-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 630 Cells
- Official record key
drug-enforcement:D-581-2014
Official wording
Reason: Labeling: Label Mixup; LACTOBACILLUS GG Capsule, 15 Billion Cells may be potentially mislabeled as ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: W003356, EXP: 6/19/2014; ZONISAMIDE, Capsule, 100 mg, NDC 64679099001, Pedigree: W003786, EXP: 6/27/2014; VENLAFAXINE HCL, Tablet, 25 mg, NDC 00093019901, Pedigree: W003860, EXP: 6/27/2014.
Code information: LACTOBACILLUS GG, Capsule, 15 Billion Cells has the following codes Pedigree: W003357, EXP: 6/19/2014; Pedigree: W003787, EXP: 6/27/2014; Pedigree: W003869, EXP: 6/27/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled