Drug product
sulfaSALAzine, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603580121.
D-994-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 299 Tablets
- Official record key
drug-enforcement:D-994-2014
Official wording
Reason: Labeling: Label Mixup: sulfaSALAzine, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: FLUCONAZOLE, Tablet, 200 mg, NDC 00172541360, Pedigree: AD65475_16, EXP: 5/28/2014; PHENYTOIN SODIUM ER, Capsule, 30 mg, NDC 00071374066, Pedigree: W003331, EXP: 6/19/2014.
Code information: has the following codes: Pedigree: AD65475_19, EXP: 5/28/2014; Pedigree: W003335, EXP: 6/19/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled