Drug product
IRBESARTAN, Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65862063830
D-717-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 Tablets
- Official record key
drug-enforcement:D-717-2014
Official wording
Reason: Labeling:Label Mixup; IRBESARTAN, Tablet, 150 mg may be potentially mislabeled as ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg, NDC 00378041501, Pedigree: W003597, EXP: 6/24/2014; CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: AD76686_7, EXP: 5/31/2014.
Code information: IRBESARTAN, Tablet, 150 mg has the following codes Pedigree: W003649, EXP: 6/25/2014; Pedigree: AD73686_7, EXP: 5/31/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled