Drug product
SEVELAMER HCl Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 58468002101
D-636-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 180 Tablets
- Official record key
drug-enforcement:D-636-2014
Official wording
Reason: Labeling:Label Mixup; SEVELAMER HCl Tablet, 800 mg may be potentially mislabeled as RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: W002857, EXP: 6/7/2014.
Code information: SEVELAMER HCl Tablet, 800 mg has the following code Pedigree: W002858, EXP: 6/7/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled