Drug product
TOLTERODINE TARTRATE ER, Capsule, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00009519001.
D-780-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 Capsules
- Official record key
drug-enforcement:D-780-2014
Official wording
Reason: Labeling: Label Mixup: TOLTERODINE TARTRATE ER, Capsule, 2 mg may be potentially mislabeled as one of the following drugs: RANOLAZINE ER , Tablet, 500 mg, NDC 61958100301, Pedigree: AD62995_7, EXP: 5/29/2014; FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe), NDC 00904759160, Pedigree: W002717, EXP: 6/6/2014.
Code information: TOLTERODINE TARTRATE ER, Capsule, 2 mg has the following codes: Pedigree: AD65478_1, EXP: 5/29/2014; Pedigree: W002724, EXP: 6/6/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled