Drug product
CILOSTAZOL, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054004421.
D-792-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 Tablets
- Official record key
drug-enforcement:D-792-2014
Official wording
Reason: Labeling: Label Mixup: CILOSTAZOL, Tablet, 100 mg may be potentially mislabeled as the following drug: CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: W003469, EXP: 6/20/2014.
Code information: CILOSTAZOL, Tablet, 100 mg has the following codes: Pedigree: W003470, EXP: 6/20/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled