Multi-event June 2020 FDA Recall Chloraprep One-step by Carefusion 213, Llc

This Multi-event Class I drug recall was voluntarily initiated by Carefusion 213, Llc on June 23, 2020 for the product Chloraprep One-step. The FDA reported the reason for recall as non-sterility. The product was distributed in Puerto Rico, Guam, United Arab Emirates, Bahrain, Brazil, Democratic Republic of the Congo, Chile, Colombia, United Kingdom of Great Britain and Northern Ireland, Hong Kong, Israel, Kuwait, Oman, Qatar, Saudi Arabia, Singapore, and the recall is currently terminated.

Reported Recall Events

D-1510-2020 TERMINATED D-1509-2020 TERMINATED D-1511-2020 TERMINATED

Recall Number: D-1510-2020

Reason for Recall
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Initiated
06-23-2020
Reported
08-26-2020
Quantity
2,800,800 applicators

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85903
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Puerto Rico, Guam, United Arab Emirates, Bahrain, Brazil, Democratic Republic of the Congo, Chile, Colombia, United Kingdom of Great Britain and Northern Ireland, Hong Kong, Israel, Kuwait, Oman, Qatar, Saudi Arabia, Singapore,
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-28-2022
Product Description About Product Description
Full technical description of the product.
ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-11

Batch or Lot Expiration Information

Lot# : 7194739, Exp. 06/25/2020; 7214841, Exp. Date 07/17/2020; 7213558, Exp. Date 07/16/2020; 7227839, Exp. Date 07/30/2020; 7276589, Exp. Date 09/20/2020; 7198824, Exp. Date 06/29/2020; 7275718, Exp. Date 09/19/2020; 7289776, Exp. Date 09/30/2020; 7306916, Exp. Date 10/12/2020; 8011665, Exp. Date 12/14/2020; 8015801, Exp. Date 12/18/2020; 8031857, Exp. Date 01/31/2021; 8033645, Exp. Date 01/31/2021; 8127657, Exp. Date 04/30/2021; 8137527, 8157141, 8158638, Exp. Date 05/31/2021; 8164530, Exp. Date 06/30/2021; 8220737, Exp. Date 07/31/2021; 8235991, Exp. Date 08/31/2021; 8043978, Exp. Date 01/31/2021; 8306694, Exp. Date 10/31/2021; 8334983, Exp. Date 11/30/2021; 9031893, 9038599, 9042938, Exp. Date 01/31/2022; 9051563, 9053560, 9072856, Exp. Date 02/28/2022; 9086532, Exp. Date 03/31/2022; 9137904, Exp. Date 05/31/2022; 9087985, Exp. Date 03/31/2022; 9191256, 9168975, Exp. Date 06/30/2022; 9218464, 9218595, Exp. Date 07/31/2022; 9228305, 9241932, 9247742, 9249471, Exp. Date 08/31/2022; 9269603, Exp. Date 09/30/2022; 9296395, 9295914, 9311076, Exp. Date 10/31/2022; 9316348, 9324565, 9345911, Exp. Date 11/30/2022; 9305775, Exp. Date 10/31/2022; 0011737, Exp. Date 12/31/2022; 0023790, 0037279, Exp. Date 01/31/2023.

Recall Number: D-1509-2020

Reason for Recall
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Initiated
06-23-2020
Reported
08-26-2020
Quantity
12,500 applicators

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85903
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Puerto Rico, Guam, United Arab Emirates, Bahrain, Brazil, Democratic Republic of the Congo, Chile, Colombia, United Kingdom of Great Britain and Northern Ireland, Hong Kong, Israel, Kuwait, Oman, Qatar, Saudi Arabia, Singapore,
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-28-2022
Product Description About Product Description
Full technical description of the product.
BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile Solution, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 54365-400-32

Batch or Lot Expiration Information

Lot# : 0065386 Exp. 2/28/2023; 0091666 Exp. 3/31/2023

Affected Packages Involved in this Recall

54365-400-32 Chloraprep One-step

Recall Number: D-1511-2020

Reason for Recall
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Initiated
06-23-2020
Reported
08-26-2020
Quantity
4,272,300 applicators

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85903
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Puerto Rico, Guam, United Arab Emirates, Bahrain, Brazil, Democratic Republic of the Congo, Chile, Colombia, United Kingdom of Great Britain and Northern Ireland, Hong Kong, Israel, Kuwait, Oman, Qatar, Saudi Arabia, Singapore,
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-28-2022
Product Description About Product Description
Full technical description of the product.
ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-01

Batch or Lot Expiration Information

Lot# : 7240735, Exp. Date 08/09/2020; 7235540, Exp. Date. 08/06/2020; 7297579, Exp. Date 10/08/2020; 8003727, Exp. Date 11/29/2020; 8011688, 8012808, Exp.. Date 12/18/2020; 8095620, 8087784, 8095620, Exp. Date 03/31/2021; 8106737, 8130509, Exp. Date 04/30/2021; 8165721, 8187644, Exp. Date 06/30/2021; 8205560, Exp. Date 07/31/2021; 8247508, Exp. Date 08/31/2021; 8289654, Exp. Date 09/30/2021; 8155991, Exp. Date 05/31/2021; 8304783, Exp. Date 10/31/2021; 8337646, 8332585, 8338794, Exp. Date 11/30/2021; 9007921, 9015917, 9015920, Exp. date 12/31/2021; 9030934, 9045819, Exp. Date 01/31/2022; 9052554, 9059817, 9046572, 9071761, Exp. Date 02/28/2022; 9087982, 9087980, 9100768, 9101529, 9092575, 9105675, Exp. Date 03/31/2022; 9113528, 9123753, 9133928, Exp. Date 04/30/2022; 9135816, 9165856, Exp. Date 05/31/2022; 9199815, 9166196, 9198900, 9199815, 9194257, 9200420, Exp. Date 06/30/2022; 9205441, Exp. Date 07/31/2022; 9233323, 9233645, 9241929, 9238871, 9253785, Exp. Date 08/31/2022; 9261886, 9278673, 9266348, 9289666, Exp. Date 09/30/2022; 9293445, 9291336, 9297772, 9311057, 9305777, Exp. Date 10/31/2022; 9326162, 9344775, 9345956, Exp. Date 11/30/2022; 9352330, 0008777, 0016325, Exp. Date 12/31/2022; 0021072, 0030959, Exp. Date 01/31/2023, 0104864, Exp. Date 03/31/2023.