Drug product
FLECAINIDE ACETATE, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054001125.
D-788-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-788-2014
Official wording
Reason: Labeling: Label Mixup: FLECAINIDE ACETATE, Tablet, 100 mg may be potentially mislabeled as the following drug: COLESTIPOL HCL MICRONIZED, Tablet, 1 g, NDC 59762045001, Pedigree: AD56847_1, EXP: 5/21/2014.
Code information: FLECAINIDE ACETATE, Tablet, 100 mg has the following codes: Pedigree: AD56847_4, EXP: 5/21/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled