Drug product
medroxyPROGESTERone ACETATE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762374202
D-647-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-647-2014
Official wording
Reason: Labeling:Label Mixup; medroxyPROGESTERone ACETATE, Tablet, 10 mg may be potentially mislabeled as hydrALAZINE HCl, Tablet, 100 mg, NDC 23155000401, Pedigree: AD46312_13, EXP: 5/16/2014.
Code information: medroxyPROGESTERone ACETATE, Tablet, 10 mg has the following code Pedigree: AD46312_19, EXP: 5/16/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled