Drug product
FIDAXOMICIN Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 52015008001
D-608-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 120 Tablets
- Official record key
drug-enforcement:D-608-2014
Official wording
Reason: Labeling: Label Mixup; FIDAXOMICIN Tablet, 200 mg may be potentially mislabeled as BENAZEPRIL HCL, Tablet, 40 mg, NDC 65162075410, Pedigree: W003918, EXP: 6/28/2014.
Code information: FIDAXOMICIN, Tablet, 200 mg has the following code Pedigree: W003920, EXP: 6/28/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled