Drug product
buPROPion HCl ER Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 47335073886
D-573-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 Tablets
- Official record key
drug-enforcement:D-573-2014
Official wording
Reason: Labeling: Label Mixup; buPROPion HCl ER Tablet, 200 mg may be potentially mislabeled as AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: W002726, EXP: 6/6/2014.
Code information: buPROPion HCl ER, Tablet, 200 mg has the following code Pedigree: W002727, EXP: 6/6/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled