Drug product
ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator, CareFusion, El Paso, TX 79912 --- NDC 054365-400-11
D-0029-2018
Product summary
- Event
- Event 78124
- Status
- Terminated
- Classification
- Class II
- Quantity
- 628,000 applicators
- Official record key
drug-enforcement:D-0029-2018
Official wording
Reason: Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear), however, the correct label should be Chloroprep with Tint (Hi Lite Orange)
Code information: Lot 7096622, exp 3/21/2020
Distribution pattern: IL, MO, PA, TN, & VA
Derived failure modes
-
Labeling or packaging
Labeling; Label Mixup