Drug product
glyBURIDE, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093834301.
D-854-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 500 Tablets
- Official record key
drug-enforcement:D-854-2014
Official wording
Reason: Labeling: Label Mixup: glyBURIDE, Tablet, 2.5 mg may have potentially been mislabeled as one of the following drugs: sulfaSALAzine, Tablet, 500 mg, NDC 59762500001, Pedigree: AD46265_13, EXP: 5/15/2014; ENTECAVIR, Tablet, 0.5 mg, NDC 00003161112, Pedigree: W003687, EXP: 6/26/2014; RALTEGRAVIR, Tablet, 400 mg, NDC 00006022761, Pedigree: AD21790_22, EXP: 5/1/2014; carBAMazepine ER, Tablet, 100 m
Code information: glyBURIDE, Tablet, 2.5 mg has the following codes: Pedigree: AD46265_22, EXP: 5/15/2014; Pedigree: W003688, EXP: 5/31/2014; Pedigree: AD21790_55, EXP: 5/1/2014; Pedigree: AD30140_34, EXP: 5/7/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled