Drug product
NIFEdipine ER, Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591319401.
D-970-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-970-2014
Official wording
Reason: Labeling: Label Mixup: NIFEdipine ER, Tablet, 60 mg may have potentially been mislabeled as the following drug: NICOTINE POLACRILEX, LOZENGE, 2 mg, NDC 00135051001, Pedigree: W003749, EXP: 6/26/2014.
Code information: NIFEdipine ER, Tablet, 60 mg has the following codes: Pedigree: W003729, EXP: 6/26/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled