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
FDA recall notice · announced November 1, 2017 · Becton Dickinson &
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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
Reason for recall
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)
Notes
Distribution: IL, MO, PA, TN, & VA
Lot/code information: Lot 7096622, exp 3/21/2020
Quantity: 628,000 applicators
Status: Terminated
Products in this recall event:
- 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)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.