Drug product
REPAGLINIDE, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00169008281.
D-868-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 500 Tablets
- Official record key
drug-enforcement:D-868-2014
Official wording
Reason: Labeling: Label Mixup: REPAGLINIDE, Tablet, 1 mg may have potentially been mislabeled as one of the following drugs: VALSARTAN, Tablet, 40 mg, NDC 00078042315, Pedigree: AD52372_1, EXP: 5/17/2014; GUAIFENESIN, Tablet, 200 mg, NDC 00904515460, Pedigree: W002853, EXP: 6/7/2014; MAGNESIUM CHLORIDE, Tablet, 64 mg, NDC 68585000575, Pedigree: W003923, EXP: 6/28/2014.
Code information: REPAGLINIDE, Tablet, 1 mg has the following codes: Pedigree: AD52387_1, EXP: 5/17/2014; Pedigree: W002855, EXP: 6/7/2014; Pedigree: W003924, EXP: 6/28/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled