Drug product
NICOTINE POLACRILEX Gum, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 24385059471
D-538-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50 Pieces of Gum
- Official record key
drug-enforcement:D-538-2014
Official wording
Reason: Labeling: Label Mixup; NICOTINE POLACRILEX Gum, 2 mg may be potentially mislabeled as SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: AD54586_4, EXP: 5/21/2014.
Code information: NICOTINE POLACRILEX Gum, 2 mg has the following code Pedigree: AD54586_7, EXP: 3/31/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled