Drug product
MAGNESIUM GLUCONATE Tablet, 500 mg (27 mg Elem Mg), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 35046000322
D-546-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 Tablets
- Official record key
drug-enforcement:D-546-2014
Official wording
Reason: Labeling: Label Mixup; MAGNESIUM GLUCONATE Tablet, 500 mg (27 mg Elem Mg) may be potentially mislabeled as FLUVASTATIN, Capsule, 20 mg, NDC 00378802077, Pedigree: W002655, EXP: 6/4/2014.
Code information: MAGNESIUM GLUCONATE Tablet, 500 mg (27 mg Elem Mg) has the following code Pedigree: W002687, EXP: 6/5/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled