Drug product
ENTECAVIR, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00003161112.
D-770-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 Tablets
- Official record key
drug-enforcement:D-770-2014
Official wording
Reason: Labeling: Label Mixup: ENTECAVIR, Tablet, 0.5 mg may be potentially mis-labeled as one of the following drugs: ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD30140_25, EXP: 5/7/2014; aMILoride HCl, Tablet, 5 mg, NDC 64980015101, Pedigree: W003686, EXP: 6/26/2014; ATOMOXETINE HCL, Capsule, 80 mg, NDC 00002325030, Pedigree: AD60272_49, EXP: 5/22/2014.
Code information: ENTECAVIR, Tablet, 0.5 mg has the following codes: Pedigree: AD30140_28, EXP: 5/7/2014; Pedigree: W003687, EXP: 6/26/2014; Pedigree: AD60272_58. EXP: 5/22/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
Labeling: Label Mixup