Chloraprep One-step Solution
FDA Recall NDC 54365-400
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 11 recorded enforcement report(s) associated with Chloraprep One-step (NDC 54365-400). A significant event, classified as Class II, was initiated on May 15, 2025 by Carefusion 213 Llc. The reported reason for this action was: "Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
D-0441-2025D-0259-2025D-1168-2023D-0373-2021D-0348-2021D-0344-2021D-0343-2021D-0347-2021D-0265-2021D-0268-2021D-1509-2020
Class II Ongoing
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
May 15, 2025
May 28, 2025
385,200 applicators
Recall Profile & Regulatory Data
Event ID
96879
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
CareFusion 213, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S.
Product Description
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.
Batch or Lot Expiration Information
Lot# s: 3354127 and 3350974, Exp Date: 12/31/2026
Affected Packages Involved in this Recall
54365-400-31Product
Class I Ongoing
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Feb 14, 2025
Mar 19, 2025
205,440 applicators
Recall Profile & Regulatory Data
Event ID
96262
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
CareFusion 213, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Canada
Product Description
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.
Batch or Lot Expiration Information
Lot# : 3200240, Exp 6/30/2026
Affected Packages Involved in this Recall
54365-400-31Product
Class II Completed
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
Sep 27, 2023
398,160 cartons
Recall Profile & Regulatory Data
Event ID
92917
Classification
Class II
Enforcement Status
Completed
Recalling Firm
CareFusion 213, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed nationwide to 100 consignees. Please refer to consignee list.
Product Description
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
Affected Packages Involved in this Recall
54365-400-31Product
Class I Terminated
Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.
Apr 20, 2021
May 19, 2021
707,050 eaches
Recall Profile & Regulatory Data
Event ID
87715
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
CareFusion 213, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Jun 21, 2023
Product Description
BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and 70% v/v Isopropyl alcohol (IPA)) Sterile Solution, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-38
Batch or Lot Expiration Information
Lot# : 0108186, Exp. 4/30/2023; 0327867, 0327868, 0328213, 0338656, 0339071, 0328947, 0328949, 0329475, 0329477, 0330457, 0330955, 0330606 0333826, 0333852, 0333855, 0334119, 0335787, 0335792, 0335029, 0336506 0336972, 0336051, 0337245, 0337025, 0338653, 0338542, 0338852, 0339892 0339457, Exp. 11/30/2023
Affected Packages Involved in this Recall
54365-400-38Product
Class II Terminated
Lack of Assurance of Sterility: 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.
Mar 19, 2021
May 05, 2021
14,275,400 cartons
Recall Profile & Regulatory Data
Event ID
87592
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
CareFusion 213, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA and to Singapore, Chile, Oman, Columbia, United Arab Emirates, South Africa, Kuwait, Democratic Republic of the Congo, Qatar, Bahrain, Hong Kong, Brazil.
Termination Date
Sep 29, 2022
Product Description
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415
Batch or Lot Expiration Information
Lot# Lot and Exp Date: 0018578, 11/30/2022; 0058277, 2/28/2023; 0059141, 2/28/2023; 0066365, 2/28/2023; 0067289, 3/31/2023; 0070866, 3/31/2023; 0074038, 3/31/2023; 0076034, 3/31/2023; 0084619, 3/31/2023; 0086158, 3/31/2023; 0090894, 3/31/2023; 0093903, 3/31/2023; 0095838, 3/31/2023; 0097561, 3/31/2023; 0098470, 3/31/2023; 0100383, 2/28/2023; 0109632, 4/30/2023; 0111185, 4/30/2023; 0113339, 4/30/2023; 0115853, 4/30/2023; 0121982, 4/30/2023; 0122192, 4/30/2023; 0122193, 4/30/2023; 0122194, 4/30/2023; 0128821, 4/30/2023; 0129409, 4/30/2023; 0135287, 4/30/2023; 0157083, 5/31/2023; 0161219, 5/31/2023; 0164032, 6/30/2023; 0164595, 5/31/2023; 0168228, 6/30/2023; 0177338, 6/30/2023; 0177384, 6/30/2023; 0178587, 6/30/2023; 0198836, 7/31/2023; 0199909, 6/30/2023; 0204887, 7/31/2023; 0205674, 6/30/2023; 0206366, 7/31/2023; 0207651, 7/31/2023; 0210578, 7/31/2023; 0227493, 7/31/2023; 0241043, 8/31/2023; 0249695, 8/31/2023; 0252883, 8/31/2023; 0254864, 8/31/2023; 0255091, 8/31/2023; 0259156, 9/30/2023; 0263754, 9/30/2023; 0267575, 9/30/2023; 0272405, 9/30/2023; 0300187, 10/31/2023; 0304315, 10/31/2023; 0305488, 10/31/2023; 0306841, 10/31/2023; 0307140, 9/30/2023; 0312694, 10/31/2023; 0313824, 10/31/2023; 0319649, 11/30/2023; 0324409, 11/30/2023; 0325577, 11/30/2023; 0326746, 11/30/2023; 0330938, 11/30/2023; 0335971, 11/30/2023; 0340937, 11/30/2023; 0347570, 12/31/2023; 0347571, 12/31/2023; 0355671, 12/31/2023; 0356362, 12/31/2023; 1008758, 12/31/2023; 1009747, 12/31/2023; 1028187, 1/31/2024; 1033578, 1/31/2024; 1034948, 1/31/2024; 1035662, 1/31/2024; 1036544, 1/31/2024; 1055547, 2/29/2024; 1060432, 2/29/2024; 9324226, 10/31/2022; 9343836, 11/30/2022; 9344810, 10/31/2022
Affected Packages Involved in this Recall
54365-400-33Product
March 2021 Class I Recall: Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
Recall Number
Class I Terminated
Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
Mar 19, 2021
May 05, 2021
1,434,000 cartons
Recall Profile & Regulatory Data
Event ID
87592
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
CareFusion 213, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA and to Singapore, Chile, Oman, Columbia, United Arab Emirates, South Africa, Kuwait, Democratic Republic of the Congo, Qatar, Bahrain, Hong Kong, Brazil.
Termination Date
Sep 29, 2022
Product Description
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415
Batch or Lot Expiration Information
Lot# Lot and Exp Date: 0107872, 4/30/2023; 0108556, 4/30/2023; 0148278, 4/30/2023; 0151978, 5/31/2023; 0155534, 5/31/2023; 0157085, 5/31/2023; 0160618, 5/31/2023; 0167907, 5/31/2023
Affected Packages Involved in this Recall
54365-400-33Product
March 2021 Class I Recall: Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
Recall Number
Class I Terminated
Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
Mar 19, 2021
May 05, 2021
952,100 cartons
Recall Profile & Regulatory Data
Event ID
87592
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
CareFusion 213, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA and to Singapore, Chile, Oman, Columbia, United Arab Emirates, South Africa, Kuwait, Democratic Republic of the Congo, Qatar, Bahrain, Hong Kong, Brazil.
Termination Date
Sep 29, 2022
Product Description
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-32 REF 930400
Batch or Lot Expiration Information
Lot# Lot and Exp Date: 0065386, 2/28/2023; 0085419, 3/31/2023; 0091666, 3/31/2023; 0149328, 4/30/2023; 0151977, 5/31/2023; 0161217, 5/31/2023; 0175874, 6/30/2023; 0176660, 6/30/2023; 0188805, 6/30/2023; 0211068, 7/31/2023
Affected Packages Involved in this Recall
54365-400-32Product
Class II Terminated
Lack of Assurance of Sterility: 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.
Mar 19, 2021
May 05, 2021
24,969,700 cartons
Recall Profile & Regulatory Data
Event ID
87592
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
CareFusion 213, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA and to Singapore, Chile, Oman, Columbia, United Arab Emirates, South Africa, Kuwait, Democratic Republic of the Congo, Qatar, Bahrain, Hong Kong, Brazil.
Termination Date
Sep 29, 2022
Product Description
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-32 REF 930400
Batch or Lot Expiration Information
Lot# Lot and Exp Date: 0010759, 11/30/2022; 0025045, 11/30/2022; 0035136, 12/31/2022; 0054691, 2/28/2023; 0057018, 2/28/2023; 0058944, 2/28/2023; 0062656, 2/28/2023; 0063728, 2/28/2023; 0063740, 2/28/2023; 0064594, 2/28/2023; 0065288, 2/28/2023; 0066368, 2/28/2023; 0067288, 3/31/2023; 0069106, 3/31/2023; 0070865, 3/31/2023; 0071359, 3/31/2023; 0072872, 3/31/2023; 0073232, 3/31/2023; 0076029, 3/31/2023; 0077515, 3/31/2023; 0077519, 3/31/2023; 0078347, 3/31/2023; 0079853, 3/31/2023; 0080632, 3/31/2023; 0081061, 3/31/2023; 0081062, 3/31/2023; 0084750, 3/31/2023; 0084754, 3/31/2023; 0084758, 3/31/2023; 0085418, 3/31/2023; 0088774, 3/31/2023; 0090545, 3/31/2023; 0090949, 3/31/2023; 0091664, 3/31/2023; 0092927, 3/31/2023; 0093445, 3/31/2023; 0094039, 3/31/2023; 0005878, 3/31/2023; 0097559, 3/31/2023; 0098525, 3/31/2023; 0099419, 2/28/2023; 0099421, 3/31/2023; 0100379, 3/31/2023; 0105130, 3/31/2023; 0105985, 3/31/2023; 0106926, 4/30/2023; 0106937, 4/30/2023; 0111775, 4/30/2023; 0112982, 4/30/2023; 0113301, 4/30/2023; 0113433, 4/30/2023; 0114091, 4/30/2023; 0114101, 4/30/2023; 0115679, 4/30/2023; 0118820, 4/30/2023; 0119488, 4/30/2023; 0120668, 4/30/2023; 0121257, 4/30/2023; 0121281, 4/30/2023; 0122195, 4/30/2023; 0125774, 4/30/2023; 0126308, 4/30/2023; 0127006, 4/30/2023; 0127856, 4/30/2023; 0128820, 4/30/2023; 0129413, 4/30/2023; 0132806, 4/30/2023; 0132808, 4/30/2023; 0133318, 4/30/2023; 0135284, 4/30/2023; 0136179, 4/30/2023; 0136919, 4/30/2023; 0139776, 4/30/2023; 0139779, 4/30/2023; 0140050, 4/30/2023; 0141253, 4/30/2023; 0142167, 4/30/2023; 0143703, 4/30/2023; 0148151, 4/30/2023; 0149875, 5/31/2023; 0153587, 5/31/2023; 0154180, 5/31/2023; 0154183, 5/31/2023; 0155301, 5/31/2023; 0155611, 5/31/2023; 0156437, 5/31/2023; 0156782, 5/31/2023; 0157078, 5/31/2023; 0160601, 5/31/2023; 0161218, 5/31/2023; 0162594, 5/31/2023; 0162595, 5/31/2023; 0163255, 5/31/2023; 0164591, 6/30/2023; 0167383, 6/30/2023; 0168035, 6/30/2023; 0168225, 6/30/2023; 0169563, 6/30/2023; 0169624, 6/30/2023; 0170815, 6/30/2023; 0171463, 6/30/2023; 0171467, 6/30/2023; 0174318, 6/30/2023; 0174321, 6/30/2023; 0174763, 6/30/2023; 0176737, 6/30/2023; 0177382, 6/30/2023; 0178582, 6/30/2023; 0178584, 6/30/2023; 0188425, 6/30/2023; 0189107, 6/30/2023; 0190185, 6/30/2023; 0192851, 6/30/2023; 0197378, 6/30/2023; 0197837, 6/30/2023; 0198823, 7/31/2023; 0199710, 7/31/2023; 0199720, 6/30/2023; 0199721, 6/30/2023; 0202925, 7/31/2023; 0203832, 6/30/2023; 0204881, 6/30/2023; 0205329, 6/30/2023; 0205331, 6/30/2023; 0206178, 7/31/2023; 0206188, 7/31/2023; 0208782, 7/31/2023; 0209285, 7/31/2023; 0210048, 7/31/2023; 0210638, 7/31/2023; 0211069, 7/31/2023; 0212509, 7/31/2023; 0212627, 7/31/2023; 0213661, 7/31/2023; 0216135, 7/31/2023; 0216992, 7/31/2023; 0216995, 7/31/2023; 0225098, 7/31/2023; 0225257, 7/31/2023; 0226610, 7/31/2023; 0227802, 7/31/2023; 0227838, 7/31/2023; 0228011, 7/31/2023; 0229538, 7/31/2023; 0230050, 7/31/2023; 0230194, 7/31/2023; 0231645, 7/31/2023; 0231646, 7/31/2023; 0232170, 7/31/2023; 0232171, 7/31/2023; 0233607, 7/31/2023; 0233609, 7/31/2023; 0234326, 7/31/2023; 0236941, 8/31/2023; 0237345, 8/31/2023; 0238657, 8/31/2023; 0238658, 8/31/2023; 0239736, 8/31/2023; 0240258, 8/31/2023; 0240259, 8/31/2023; 0241313, 8/31/2023; 0241656, 8/31/2023; 0242880, 8/31/2023; 0244660, 8/31/2023; 0244662, 8/31/2023; 0245775, 7/31/2023; 0246170, 8/31/2023; 0246478, 8/31/2023; 0247206, 8/31/2023; 0248555, 8/31/2023; 0248737, 7/31/2023; 0252884, 8/31/2023; 0253778, 8/31/2023; 0253810, 8/31/2023; 0254567, 8/31/2023; 0254731, 8/31/2023; 0255645, 8/31/2023; 0258252, 8/31/2023; 0258659, 8/31/2023; 0259065, 9/30/2023; 0259898, 9/30/2023; 0260681, 9/30/2023; 0261975, 9/30/2023; 0262729, 9/30/2023; 0265184, 9/30/2023; 0279818, 9/30/2023; 0308327, 10/31/2023; 0309811, 10/31/2023; 0309816, 10/31/2023; 0311453, 10/31/2023; 0312698, 10/31/2023; 0314634, 10/31/2023; 0315662, 10/31/2023; 0316151, 11/30/2023; 0316372, 10/31/2023; 0317672, 11/30/2023; 0318148, 11/30/2023; 0321438, 11/30/2023; 0322315, 11/30/2023; 0323068, 11/30/2023; 0323448, 11/30/2023; 0323503, 11/30/2023; 0324263, 11/30/2023; 0324264, 11/30/2023; 0328929, 11/30/2023; 0329153, 11/30/2023; 0329996, 11/30/2023; 0330665, 11/30/2023; 0335120, 11/30/2023; 0335799, 11/30/2023; 0337020, 11/30/2023; 0338067, 11/30/2023; 0338974, 11/30/2023; 0340677, 11/30/2023; 0343589, 11/30/2023; 0343898, 11/30/2023; 0343903, 11/30/2023; 0344397, 12/31/2023; 0345866, 11/30/2023; 0345870, 11/30/2023; 0346321, 12/31/2023; 0349906, 12/31/2023; 0349907, 12/31/2023; 0350058, 12/31/2023; 0350772, 12/31/2023; 0351193, 12/31/2023; 0351226, 12/31/2023; 0351821, 12/31/2023; 0352445, 11/30/2023; 0352694, 11/30/2023; 0353338, 12/31/2023; 0354300, 12/31/2023; 1008731, 12/31/2023; 1009535, 12/31/2023; 1009538, 12/31/2023; 1012621, 12/31/2023; 1013421, 12/31/2023; 1013423, 12/31/2023; 1014132, 12/31/2023; 1014134, 12/31/2023; 1018037, 12/31/2023; 1018799, 12/31/2023; 1019769, 1/31/2024; 1020849, 1/31/2024; 1021641, 1/31/2024; 1021805, 1/31/2024; 1022415, 1/31/2024; 1022719, 1/31/2024; 1025105, 1/31/2024; 1025854, 1/31/2024; 1025950, 1/31/2024; 1026350, 1/31/2024; 1027907, 1/31/2024; 1028547, 1/31/2024; 1028799, 1/31/2024; 1029694, 1/31/2024; 1030487, 1/31/2024; 1032505, 1/31/2024; 1032717, 1/31/2024; 1033620, 1/31/2024; 1033708, 1/31/2024; 1034917, 1/31/2024; 1035640, 1/31/2024; 1036582, 1/31/2024; 1038982, 1/31/2024; 1039915, 1/31/2024; 1040816, 1/31/2024; 1041348, 1/31/2024; 1041631, 1/31/2024; 1043285, 2/29/2024; 1043350, 1/31/2024; 1048645, 2/29/2024; 1048656, 2/29/2024; 1049461, 2/29/2024; 1049465, 2/29/2024; 1050250, 2/29/2024; 1051583, 2/29/2024; 1051918, 2/29/2024; 1054135, 2/29/2024; 1054728, 2/29/2024; 1055950, 2/29/2024; 1055969, 2/29/2024; 1056752, 2/29/2024; 1057007, 2/29/2024; 1057987, 2/29/2024; 1057988, 2/29/2024; 1059824, 2/29/2024; 1060836, 2/29/2024; 1061724, 2/29/2024; 9305899, 10/31/2022; 9309166, 10/31/2022; 9339182, 11/30/2022
Affected Packages Involved in this Recall
54365-400-32Product
Class I Terminated
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.
Jul 07, 2020
Mar 03, 2021
988 cartons
Recall Profile & Regulatory Data
Event ID
86998
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
CareFusion 213, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed in Puerto Rico and Oman
Termination Date
Sep 29, 2022
Product Description
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-32 REF 930400
Batch or Lot Expiration Information
Lot# All lots including but not limited to the following lots distributed in Zone IV:
Lot# 0161217 Exp. 05/31/2023; 0211068 Exp. 07/31/2023; 0176660 Exp. 06/30/2023; 0188805 Exp. 06/30/2023; 0175874 Exp. 06/30/2023; 0151977 Exp. 05/31/2023; 0149328 Exp. 04/30/2023; 0085419 Exp. 03/31/2023
Affected Packages Involved in this Recall
54365-400-32Product
Class I Terminated
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.
Jul 07, 2020
Mar 03, 2021
400 cartons
Recall Profile & Regulatory Data
Event ID
86998
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
CareFusion 213, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed in Puerto Rico and Oman
Termination Date
Sep 29, 2022
Product Description
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
Batch or Lot Expiration Information
Lot# 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.
Affected Packages Involved in this Recall
54365-400-33Product
Class I Terminated
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Jun 23, 2020
Aug 26, 2020
12,500 applicators
Recall Profile & Regulatory Data
Event ID
85903
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
CareFusion 213, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
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
Sep 28, 2022
Product Description
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
54365-400-32Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
