Drug product
NICOTINE POLACRILEX Lozenge, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49348085216
D-584-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 70 Lozenges
- Official record key
drug-enforcement:D-584-2014
Official wording
Reason: Labeling: Label Mixup; NICOTINE POLACRILEX Lozenge, 2 mg may be potentially mislabeled as VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, NDC 60258016001, Pedigree: W003361, EXP: 6/19/2014.
Code information: NICOTINE POLACRILEX, Lozenge, 2 mg has the following code Pedigree: W003393, EXP: 6/19/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled