Drug product
glyBURIDE, Tablet, 1.25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093834201.
D-853-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 Tablets
- Official record key
drug-enforcement:D-853-2014
Official wording
Reason: Labeling: Label Mixup: glyBURIDE, Tablet, 1.25 mg may have potentially been mislabeled as one of the following drugs: CYPROHEPTADINE HCL, Tablet, 4 mg, NDC 60258085001, Pedigree: W003676, EXP: 6/25/2014; AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: AD21790_1, EXP: 5/1/2014.
Code information: glyBURIDE, Tablet, 1.25 mg has the following codes: Pedigree: W003677, EXP: 2/28/2014; Pedigree: AD21790_10, EXP: 2/28/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled