Drug product
DARUNAVIR Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59676056630
D-641-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 Tablets
- Official record key
drug-enforcement:D-641-2014
Official wording
Reason: Labeling:Label Mixup; DARUNAVIR Tablet, 800 mg may be potentially mislabeled as HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg, NDC 52544016201, Pedigree: W004005, EXP: 7/1/2014.
Code information: DARUNAVIR, Tablet, 800 mg has the following code Pedigree: W003929, EXP: 7/1/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled