August 2023 FDA Recall Chloraprep One-step by Carefusion 213, Llc
D-1168-2023 - Stability data does not support expiry
This Class II drug recall was voluntarily initiated by Carefusion 213, Llc on August 25, 2023 for the product Chloraprep One-step. The FDA reported the reason for recall as stability data does not support expiry. The product was distributed Nationwide and the recall is currently completed.
Recall Number: D-1168-2023
Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides.
08-25-2023
09-27-2023
398,160 cartons
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
CareFusion 213, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed nationwide to 100 consignees. Please refer to consignee list.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (1 ml) each, 60 applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-31 REF 930480 Product is packaged in the following manner: There is one (1) sterile applicator (sponge) per pouch. Each inner carton contains sixty (60) pouches. There are four (4) inner cartons per shipping case (total of 240 pouches per case).
Batch or Lot Expiration Information
Lot# 2272350, Exp. Date 09/30/2025 and
Lot# 2301939, Exp. Date 09/30/2025
