Drug product
glyBURIDE MICRONIZED, Tablet, 3 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093803501.
D-850-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 101 Tablets
- Official record key
drug-enforcement:D-850-2014
Official wording
Reason: Labeling: Label Mixup: glyBURIDE MICRONIZED, Tablet, 3 mg may have potentially been mislabeled as the following drug: DIGOXIN, Tablet, 0.125 mg, NDC 00115981101, Pedigree: W003154, EXP: 6/13/2014.
Code information: glyBURIDE MICRONIZED, Tablet, 3 mg has the following codes: Pedigree: W003155, EXP: 6/13/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled