Recalls / Class I

Class ID-0268-2021

Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.

Product

BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.01 fl. oz. (3 ml) each, 25 Applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415

Brand name: Chloraprep One-step
Generic name: Chlorhexidine Gluconate And Isopropyl Alcohol
Active ingredients: Chlorhexidine Gluconate, Isopropyl Alcohol
Route: Topical
NDC: 54365-400
FDA application: NDA020832
Affected lot / code info: All lots including but not limited to the following lots distributed in Zone IV: Lot # 0107872, Exp. 04/30/2023; 0108556, Exp. 04/30/2023; 0148278, Exp. 04/30/2023; 0151978, Exp. 05/31/2023; 0155534, Exp. 05/31/2023; 0157085, Exp. 05/31/2023; 0160618, Exp. 05/31/2023; 0167907, Exp. 05/31/2023.

Why it was recalled

Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.

Recalling firm

Firm: CareFusion 213, LLC
Notification channel: Letter
Type: Voluntary: Firm initiated
Address: 1550 Northwestern Dr, N/A, El Paso, Texas 79912-8000

Distribution

Quantity: 400 cartons
Distribution pattern: Distributed in Puerto Rico and Oman

Timeline

Recall initiated: 2020-07-07
FDA classified: 2021-02-19
Posted by FDA: 2021-03-03
Terminated: 2022-09-29
Status: Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0268-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.