Drug product
REPAGLINIDE, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00169008481.
D-869-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 500 Tablets
- Official record key
drug-enforcement:D-869-2014
Official wording
Reason: Labeling: Label Mixup: REPAGLINIDE, Tablet, 2 mg may have potentially been mislabeled as one of the following drugs: COLCHICINE, Tablet, 0.6 mg, NDC 64764011907, Pedigree: AD46419_1, EXP: 5/16/2014; PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, NDC 00032121207, Pedigree: AD70639_7, EXP: 5/29/2014; DARUNAVIR, Tablet, 800 mg, NDC 59676056630, Pedigree: W003929, EXP: 7/1/2014.
Code information: REPAGLINIDE, Tablet, 2 mg has the following codes: Pedigree: AD46419_4, EXP: 5/16/2014; Pedigree: AD70639_13, EXP: 5/29/2014; Pedigree: W003925, EXP: 7/1/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled