Drug product
AMANTADINE HCL, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00832011100.
D-1013-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2400 Tablets
- Official record key
drug-enforcement:D-1013-2014
Official wording
Reason: Labeling: Label Mixup: AMANTADINE HCL, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: MAGNESIUM CHLORIDE, Tablet, 64 mg, NDC 68585000575, Pedigree: AD52993_4, EXP: 5/17/2014; QUEtiapine FUMARATE, Tablet, 25 mg, NDC 65862048901, Pedigree: AD49582_22, EXP: 4/30/2014.
Code information: AMANTADINE HCL, Tablet, 100 mg has the following codes: Pedigree: AD54475_1, EXP: 5/20/2014; Pedigree: AD54475_4, EXP: 5/20/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled