Drug product
LACTASE ENZYME Tablet, 3000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 24385014976
D-537-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,872 Tablets
- Official record key
drug-enforcement:D-537-2014
Official wording
Reason: Labeling: Label Mixup; LACTASE ENZYME Tablet, 3000 units may be potentially mislabeled as BENZOCAINE/MENTHOL, LOZENGE, 15 mg/3.6 mg, NDC 63824072016, Pedigree: AD21811_4, EXP: 5/1/2014; ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg, NDC 46122010478, Pedigree: W003722, EXP: 4/30/2014; guaiFENesin ER, Tablet, 600 mg, NDC 45802049878, Pedigree: AD30140_37, EXP: 5/7/2014; CALCIUM
Code information: LACTASE ENZYME Tablet, 3000 units has the following codes Pedigree: AD21846_31, EXP: 5/1/2014; Pedigree: W003721, EXP: 6/26/2014; Pedigree: AD30028_25, EXP: 5/7/2014; Pedigree: AD60240_36, EXP: 5/22/2014; Pedigree: W002700, EXP: 6/5/2014; Pedigree: AD46257_53, EXP: 5/15/2014; Pedigree: W003021, EXP: 6/12/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled