Drug product
BENZOCAINE/MENTHOL, Lozenge, 15 mg/2.6 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824073116
D-686-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32 Lozenges
- Official record key
drug-enforcement:D-686-2014
Official wording
Reason: Labeling:Label Mixup; BENZOCAINE/MENTHOL Lozenge, 15 mg/2.6 mg may be potentially mislabeled as CHOLECALCIFEROL/ CALCIUM/ PHOSPHORUS, Tablet, 120 units/105 mg/81 mg, NDC 64980015001, Pedigree: AD32345_1, EXP: 5/14/2014.
Code information: BENZOCAINE/MENTHOL, Lozenge, 15 mg/2.6 mg has the following code Pedigree: AD42592_4, EXP: 5/14/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled