ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415

Class I - Dangerous

💊 Drugs Recalled: March 19, 2021 CareFusion 213 Compounded Drugs Nationwide

What Should You Do?

Check if you have this product:
Lots and Exp dates: 0009104, 12/31/2022; 0013602, 12/31/2022; 0016431, 1/31/2023; 0022273, 1/31/2023; 0023788, 1/31/2023; 0029135, 1/31/2023; 0032694, 1/31/2023; 0038211, 1/31/2023; 0044741, 1/31/2023; 0064598, 2/28/2023; 0104862, 3/31/2023; 0127010, 4/30/2023; 0196060, 6/30/2023; 0224915, 7/31/2023; 8024958, 1/9/2021; 8025595, 1/31/2021; 8025597, 1/31/2021; 8031857, 1/31/2021; 8033645, 1/31/2021; 8038971, 1/28/2021; 8043969, 1/22/2021; 8043978, 1/31/2021; 8046513, 2/1/2021; 8046721, 1/29/2021; 8053669, 2/28/2021; 8053699, 2/28/2021; 8053947, 2/28/2021; 8055949, 2/28/2021; 8059513, 2/28/2021; 8059562, 2/28/2021; 8061970, 2/19/2021; 8064854, 2/28/2021; 8066666, 2/28/2021; 8068686, 2/28/2021; 8069986, 2/28/2021; 8073868, 2/28/2021; 8087798, 3/31/2021; 8099735, 3/31/2021; 8101641, 3/31/2021; 8106743, 4/30/2021; 8107945, 4/30/2021; 8120678, 4/30/2021; 8122947, 4/30/2021; 8131539, 4/30/2021; 8145833, 5/31/2021; 8155989, 5/31/2021; 8172690, 6/30/2021; 8173860, 6/30/2021; 8191600, 6/30/2021; 8221942, 7/31/2021; 8234936, 8/31/2021; 8243851, 8/31/2021; 8247688, 8/31/2021; 8250928, 8/31/2021; 8253987, 8/31/2021; 8256638, 8/31/2021; 8260782, 8/31/2021; 8265685, 9/30/2021; 8274504, 9/30/2021; 8276704, 9/30/2021; 8282698, 9/30/2021; 8284625, 9/30/2021; 8288853, 9/30/2021; 8338776, 11/30/2021; 8339985, 11/30/2021; 8351538, 12/31/2021; 8355672, 12/31/2021; 9007942, 12/31/2021; 9014571, 12/31/2021; 9017726, 1/31/2022; 9021969, 12/31/2021; 9024576, 1/31/2022; 9030949, 1/31/2022; 9078586, 3/31/2022; 9087987, 3/31/2022; 9092771, 3/31/2022; 9128867, 4/30/2022; 9129671, 4/30/2022; 9135822, 5/31/2022; 9143840, 5/31/2022; 9154907, 5/31/2022; 9154939, 5/31/2022; 9158658, 5/31/2022; 9164579, 5/31/2022; 9175663, 6/30/2022; 9176284, 6/30/2022; 9197931, 6/30/2022; 9199822, 6/30/2022; 9200426, 7/31/2022; 9205380, 7/31/2022; 9207927, 7/31/2022; 9213913, 7/31/2022; 9221459, 7/31/2022; 9224855, 7/31/2022; 9231815, 8/31/2022; 9232764, 8/31/2022; 9233646, 8/31/2022; 9235839, 8/31/2022; 9248040, 8/31/2022; 9261980, 9/30/2022; 9270896, 9/30/2022; 9301763, 10/31/2022; 9310176, 10/31/2022; 9317270, 11/30/2022; 9327966, 11/30/2022; 9327969, 11/30/2022; 9339209, 11/30/2022; 9344806, 11/30/2022; 9345964, 10/31/2022; 9351402, 12/31/2022;
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: CareFusion 213, LLC
Reason for Recall:: CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415

Product Codes/Lot Numbers:

Lots and Exp dates: 0009104, 12/31/2022; 0013602, 12/31/2022; 0016431, 1/31/2023; 0022273, 1/31/2023; 0023788, 1/31/2023; 0029135, 1/31/2023; 0032694, 1/31/2023; 0038211, 1/31/2023; 0044741, 1/31/2023; 0064598, 2/28/2023; 0104862, 3/31/2023; 0127010, 4/30/2023; 0196060, 6/30/2023; 0224915, 7/31/2023; 8024958, 1/9/2021; 8025595, 1/31/2021; 8025597, 1/31/2021; 8031857, 1/31/2021; 8033645, 1/31/2021; 8038971, 1/28/2021; 8043969, 1/22/2021; 8043978, 1/31/2021; 8046513, 2/1/2021; 8046721, 1/29/2021; 8053669, 2/28/2021; 8053699, 2/28/2021; 8053947, 2/28/2021; 8055949, 2/28/2021; 8059513, 2/28/2021; 8059562, 2/28/2021; 8061970, 2/19/2021; 8064854, 2/28/2021; 8066666, 2/28/2021; 8068686, 2/28/2021; 8069986, 2/28/2021; 8073868, 2/28/2021; 8087798, 3/31/2021; 8099735, 3/31/2021; 8101641, 3/31/2021; 8106743, 4/30/2021; 8107945, 4/30/2021; 8120678, 4/30/2021; 8122947, 4/30/2021; 8131539, 4/30/2021; 8145833, 5/31/2021; 8155989, 5/31/2021; 8172690, 6/30/2021; 8173860, 6/30/2021; 8191600, 6/30/2021; 8221942, 7/31/2021; 8234936, 8/31/2021; 8243851, 8/31/2021; 8247688, 8/31/2021; 8250928, 8/31/2021; 8253987, 8/31/2021; 8256638, 8/31/2021; 8260782, 8/31/2021; 8265685, 9/30/2021; 8274504, 9/30/2021; 8276704, 9/30/2021; 8282698, 9/30/2021; 8284625, 9/30/2021; 8288853, 9/30/2021; 8338776, 11/30/2021; 8339985, 11/30/2021; 8351538, 12/31/2021; 8355672, 12/31/2021; 9007942, 12/31/2021; 9014571, 12/31/2021; 9017726, 1/31/2022; 9021969, 12/31/2021; 9024576, 1/31/2022; 9030949, 1/31/2022; 9078586, 3/31/2022; 9087987, 3/31/2022; 9092771, 3/31/2022; 9128867, 4/30/2022; 9129671, 4/30/2022; 9135822, 5/31/2022; 9143840, 5/31/2022; 9154907, 5/31/2022; 9154939, 5/31/2022; 9158658, 5/31/2022; 9164579, 5/31/2022; 9175663, 6/30/2022; 9176284, 6/30/2022; 9197931, 6/30/2022; 9199822, 6/30/2022; 9200426, 7/31/2022; 9205380, 7/31/2022; 9207927, 7/31/2022; 9213913, 7/31/2022; 9221459, 7/31/2022; 9224855, 7/31/2022; 9231815, 8/31/2022; 9232764, 8/31/2022; 9233646, 8/31/2022; 9235839, 8/31/2022; 9248040, 8/31/2022; 9261980, 9/30/2022; 9270896, 9/30/2022; 9301763, 10/31/2022; 9310176, 10/31/2022; 9317270, 11/30/2022; 9327966, 11/30/2022; 9327969, 11/30/2022; 9339209, 11/30/2022; 9344806, 11/30/2022; 9345964, 10/31/2022; 9351402, 12/31/2022;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0350-2021

Related Recalls

BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31.

CareFusion 213

Class I - Dangerous

Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.

May 15, 2025 Compounded Drugs Nationwide View Details →

BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31.

CareFusion 213

Class I - Dangerous

Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.

Feb 14, 2025 Compounded Drugs Nationwide View Details →

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).

CareFusion 213

Class I - Dangerous

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.

Aug 25, 2023 Compounded Drugs Nationwide View Details →