Drug product
LACTOBACILLUS Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 64980012950
D-700-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,249 Tablets
- Official record key
drug-enforcement:D-700-2014
Official wording
Reason: Labeling: Label Mixup; LACTOBACILLUS Tablet may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 65162066850, Pedigree: AD62979_1, EXP: 5/23/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD62986_1, EXP: 5/23/2014; LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg), NDC 00054002025, Pedigree: AD21790_25, EXP: 5/1/2014; OMEGA-3 FATTY ACID, Capsule, 100
Code information: LACTOBACILLUS Tablet has the following codes Pedigree: AD62986_10, EXP: 5/23/2014; Pedigree: AD62992_1, EXP: 5/23/2014; Pedigree: AD22865_1, EXP: 5/2/2014; Pedigree: W003624, EXP: 1/31/2014; Pedigree: W003622, EXP: 6/25/2014; Pedigree: W003623, EXP: 10/31/2013.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled