Drug product
EFAVIRENZ, Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00056051030.
D-801-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 Tablets
- Official record key
drug-enforcement:D-801-2014
Official wording
Reason: Labeling: Label Mixup: EFAVIRENZ, Tablet, 600 mg may have potentially been mislabeled as the following drug: NIACIN ER, Tablet, 500 mg, NDC 00074307490, Pedigree: AD73637_1, EXP: 5/30/2014.
Code information: EFAVIRENZ, Tablet, 600 mg has the following codes: Pedigree: AD73646_16, EXP: 5/30/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled