Drug product
DIGOXIN, Tablet, 125 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00527132401.
D-919-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 Tablets
- Official record key
drug-enforcement:D-919-2014
Official wording
Reason: Labeling: Label Mixup: DIGOXIN, Tablet, 125 mcg may have potentially been mislabeled as the following drug: CHOLECALCIFEROL/ CALCIUM/ PHOSPHORUS, Tablet, 120 units/105 mg/81 mg, NDC 64980015001, Pedigree: W002581, EXP: 6/3/2014.
Code information: DIGOXIN, Tablet, 125 mcg has the following codes: Pedigree: AD76675_4, EXP: 6/3/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled