Drug product
MAGNESIUM GLUCONATE DIHYDRATE Tablet, 500 mg (27 mg Elemental Magnesium), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258017201
D-654-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-654-2014
Official wording
Reason: Labeling:Label Mixup; MAGNESIUM GLUCONATE DIHYDRATE Tablet, 500 mg (27 mg Elemental Magnesium) may be potentially mislabeled as hydrALAZINE HCl, Tablet, 100 mg, NDC 23155000401, Pedigree: AD30197_7, EXP: 5/9/2014.
Code information: MAGNESIUM GLUCONATE DIHYDRATE, Tablet, 500 mg (27 mg Elemental Magnesium) has the following code Pedigree: AD30197_16, EXP: 5/9/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled