Drug product
FLECAINIDE ACETATE Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162064110
D-708-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-708-2014
Official wording
Reason: Labeling:Label Mixup; FLECAINIDE ACETATE Tablet, 50 mg may be potentially mislabeled as VITAMIN B COMPLEX W/C, Tablet, NDC 00904026013, Pedigree: AD46419_7, EXP: 5/16/2014.
Code information: FLECAINIDE ACETATE Tablet, 50 mg has the following code Pedigree: AD46414_16, EXP: 5/16/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled