Drug product
RILUZOLE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00075770060.
D-813-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 120 Tablets
- Official record key
drug-enforcement:D-813-2014
Official wording
Reason: Labeling: Label Mixup: RILUZOLE, Tablet, 50 mg may have potentially been mislabeled as the following drug: LACTOBACILLUS, Tablet, 0 mg, NDC 64980012950, Pedigree: AD62986_10, EXP: 5/23/2014.
Code information: RILUZOLE, Tablet, 50 mg has the following codes: Pedigree: AD62992_11, EXP: 5/23/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled