Drug product
LEFLUNOMIDE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155004303
D-527-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 Tablets
- Official record key
drug-enforcement:D-527-2014
Official wording
Reason: Labeling: Label Mixup; LEFLUNOMIDE Tablet, 10 mg may be potentially mislabeled as DOXYCYCLINE HYCLATE, Capsule, 100 mg, NDC 00143314250, Pedigree: W002645, EXP: 6/5/2014; SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: W002623, EXP: 6/4/2014.
Code information: LEFLUNOMIDE Tablet, 10 mg has the following codes Pedigree: W002659, EXP: 6/5/2014; Pedigree: W002658, EXP: 6/4/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled