Drug product
METAXALONE Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64720032110
D-694-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-694-2014
Official wording
Reason: Labeling: Label Mixup; METAXALONE Tablet, 800 mg may be potentially mislabeled as ESTERIFIED ESTROGENS, Tablet, 0.625 mg, NDC 61570007301, Pedigree: W003736, EXP: 6/26/2014.
Code information: METAXALONE Tablet, 800 mg has the following code Pedigree: W003738, EXP: 6/26/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled