Multi-event March 2021 FDA Recall Chloraprep One-step by Carefusion 213, Llc
This Multi-event Class II drug recall was voluntarily initiated by Carefusion 213, Llc on March 19, 2021 for the product Chloraprep One-step. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0349-2021
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.
03-19-2021
05-05-2021
40,720,900 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.
Terminated
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
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.
09-29-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400
Batch or Lot Expiration Information
Lot# Lot and Exp Date: 0000192, 12/31/2022; 0007621, 12/31/2022; 0008775, 12/31/2022; 0009111, 12/31/2022; 0011738, 12/31/2022; 0011753, 12/31/2022; 0011754, 12/31/2022; 0011755, 12/31/2022; 0013604, 12/31/2022; 0015498, 12/31/2022; 0015500, 12/31/2022; 0016329, 1/31/2023; 0017929, 12/31/2022; 0021945, 1/31/2023; 0028887, 1/31/2023; 0031093, 1/31/2023; 0034660, 1/31/2023; 0035149, 1/31/2023; 0036460, 1/31/2023; 0037272, 1/31/2023; 0038213, 1/31/2023; 0038217, 1/31/2023; 0041893, 1/31/2023; 0042483, 1/31/2023; 0042501, 1/31/2023; 0043105, 1/31/2023; 0044739, 1/31/2023; 0094838, 2/28/2023; 0098051, 2/28/2023; 0104859, 3/31/2023; 0129330, 4/30/2023; 0133069, 4/30/2023; 0220728, 7/31/2023; 0223036, 7/31/2023; 8078998, 3/31/2021; 8079620, 3/31/2021; 8079621, 3/31/2021; 8082921, 3/31/2021; 8082923, 3/31/2021; 8085804, 3/31/2021; 8088708, 3/31/2021; 8089621, 3/31/2021; 8093619, 3/31/2021; 8093813, 3/31/2021; 8094833, 3/31/2021; 8096706, 3/31/2021; 8097822, 3/31/2021; 8099727, 3/31/2021; 8099783, 3/31/2021; 8100947, 3/31/2021; 8101636, 3/31/2021; 8101719, 3/31/2021; 8102691, 3/31/2021; 8103673, 4/30/2021; 8108795, 4/30/2021; 8109707, 4/30/2021; 8110645, 4/30/2021; 8110674, 4/30/2021; 8114540, 4/30/2021; 8114547, 4/30/2021; 8115574, 4/30/2021; 8116705, 4/30/2021; 8120701, 4/30/2021; 8120985, 4/30/2021; 8122873, 4/30/2021; 8122874, 4/30/2021; 8124914, 4/30/2021; 8127649, 4/30/2021; 8127650, 4/30/2021; 8129680, 4/30/2021; 8129686, 4/30/2021; 8134847, 4/30/2021; 8134850, 4/30/2021; 8136811, 5/31/2021; 8137525, 5/31/2021; 8138867, 5/31/2021; 8141821, 5/31/2021; 8143659, 5/31/2021; 8144768, 5/31/2021; 8144882, 5/31/2021; 8145889, 5/31/2021; 8150625, 5/31/2021; 8151713, 5/31/2021; 8151736, 5/31/2021; 8152581, 5/31/2021; 8156507, 5/31/2021; 8156735, 5/31/2021; 8157866, 5/31/2021; 8157993, 5/31/2021; 8158595, 5/31/2021; 8158633, 5/31/2021; 8159995, 5/31/2021; 8164525, 6/30/2021; 8165696, 6/30/2021; 8167970, 6/30/2021; 8170535, 6/30/2021; 8170538, 6/30/2021; 8171503, 6/30/2021; 8172910, 6/30/2021; 8173655, 6/30/2021; 8176731, 6/30/2021; 8177746, 6/30/2021; 8178576, 6/30/2021; 8178654, 6/30/2021; 8179928, 6/30/2021; 8179974, 6/30/2021; 8180627, 6/30/2021; 8186700, 6/30/2021; 8190916, 6/30/2021; 8190987, 6/30/2021; 8192557, 6/30/2021; 8192881, 6/30/2021; 8197514, 6/30/2021; 8197515, 6/30/2021; 8198763, 7/31/2021; 8199675, 7/31/2021; 8204574, 7/31/2021; 8206898, 7/31/2021; 8211903, 7/31/2021; 8212879, 7/31/2021; 8214989, 7/31/2021; 8214995, 7/31/2021; 8215994, 7/31/2021; 8218645, 7/31/2021; 8219946, 7/31/2021; 8219988, 7/31/2021; 8222798, 7/31/2021; 8225863, 7/31/2021; 8225868, 7/31/2021; 8228632, 8/31/2021; 8229682, 8/31/2021; 8232739, 8/31/2021; 8233569, 8/31/2021; 8235983, 8/31/2021; 8239901, 8/31/2021; 8239902, 8/31/2021; 8240966, 8/31/2021; 8241848, 8/31/2021; 8243756, 8/31/2021; 8247510, 8/31/2021; 8248570, 8/31/2021; 8249934, 8/31/2021; 8257619, 8/31/2021; 8260778, 9/30/2021; 8261945, 9/30/2021; 8261946, 9/30/2021; 8262674, 9/30/2021; 8263865, 9/30/2021; 8265679, 9/30/2021; 8267928, 9/30/2021; 8267929, 9/30/2021; 8268617, 9/30/2021; 8268618, 9/30/2021; 8269913, 9/30/2021; 8271911, 9/30/2021; 8274999, 9/30/2021; 8275615, 9/30/2021; 8275625, 9/30/2021; 8276694, 9/30/2021; 8277635, 9/30/2021; 8277637, 9/30/2021; 8282884, 9/30/2021; 8283738, 9/30/2021; 8284622, 9/30/2021; 8285592, 9/30/2021; 8288852, 9/30/2021; 8290569, 9/30/2021; 8291769, 10/31/2021; 8292703, 10/31/2021; 8292708, 10/31/2021; 8296693, 10/31/2021; 8296695, 10/31/2021; 8299673, 10/31/2021; 8303606, 10/31/2021; 8304839, 10/31/2021; 8306692, 10/31/2021; 8309553, 10/31/2021; 8310641, 10/31/2021; 8311789, 10/31/2021; 8313646, 10/31/2021; 8313687, 10/31/2021; 8319821, 10/31/2021; 8320984, 11/30/2021; 8323514, 11/30/2021; 8323745, 11/30/2021; 8325725, 11/30/2021; 8325749, 11/30/2021; 8331695, 11/30/2021; 8341526, 11/30/2021; 8344689, 11/30/2021; 8345987, 11/30/2021; 8345988, 11/30/2021; 8346840, 11/30/2021; 8347713, 11/30/2021; 8348560, 11/30/2021; 8351524, 12/31/2021; 8351527, 12/31/2021; 8354841, 12/31/2021; 8355555, 12/31/2021; 8355665, 12/31/2021; 9007932, 12/31/2021; 9008954, 12/31/2021; 9008963, 12/31/2021; 9009962, 12/31/2021; 9010973, 12/31/2021; 9014968, 12/31/2021; 9017714, 12/31/2021; 9017716, 12/31/2021; 9021962, 1/31/2022; 9022804, 12/31/2021; 9022808, 12/31/2021; 9023539, 1/31/2022; 9023541, 1/31/2022; 9028693, 1/31/2022; 9030936, 1/31/2022; 9035603, 1/31/2022; 9036759, 1/31/2022; 9036761, 1/31/2022; 9037816, 1/31/2022; 9038527, 1/31/2022; 9039888, 1/31/2022; 9039889, 1/31/2022; 9042932, 1/31/2022; 9043626, 1/31/2022; 9044570, 1/31/2022; 9049788, 2/28/2022; 9049790, 2/28/2022; 9051558, 2/28/2022; 9053553, 2/28/2022; 9053605, 2/28/2022; 9056781, 2/28/2022; 9057597, 2/28/2022; 9057600, 2/28/2022; 9058797, 2/28/2022; 9064561, 2/28/2022; 9067661, 2/28/2022; 9070712, 2/28/2022; 9072853, 2/28/2022; 9073968, 2/28/2022; 9074967, 2/28/2022; 9077861, 2/28/2022; 9079525, 3/31/2022; 9079746, 3/31/2022; 9085737, 3/31/2022; 9093920, 3/31/2022; 9094797, 3/31/2022; 9098940, 3/31/2022; 9099817, 3/31/2022; 9100771, 3/31/2022; 9100776, 3/31/2022; 9106945, 3/31/2022; 9106950, 3/31/2022; 9107765, 4/30/2022; 9107767, 4/30/2022; 9112666, 4/30/2022; 9112668, 4/30/2022; 9113527, 4/30/2022; 9114610, 4/30/2022; 9114611, 4/30/2022; 9116696, 4/30/2022; 9116698, 4/30/2022; 9119832, 4/30/2022; 9120522, 4/30/2022; 9120523, 4/30/2022; 9121774, 4/30/2022; 9122536, 4/30/2022; 9123755, 4/30/2022; 9127963, 4/30/2022; 9127968, 4/30/2022; 9128862, 4/30/2022; 9129660, 4/30/2022; 9130717, 4/30/2022; 9136917, 5/31/2022; 9138989, 5/31/2022; 9140678, 5/31/2022; 9140679, 5/31/2022; 9141792, 5/31/2022; 9143507, 5/31/2022; 9143509, 5/31/2022; 9144771, 5/31/2022; 9144772, 5/31/2022; 9154934, 5/31/2022; 9155527, 5/31/2022; 9155529, 5/31/2022; 9157896, 5/31/2022; 9161567, 5/31/2022; 9162902, 5/31/2022; 9164894, 5/31/2022; 9168973, 6/30/2022; 9171622, 6/30/2022; 9172951, 6/30/2022; 9175686, 6/30/2022; 9179857, 6/30/2022; 9190047, 6/30/2022; 9191255, 6/30/2022; 9192026, 6/30/2022; 9192028, 6/30/2022; 9194258, 6/30/2022; 9196197, 6/30/2022; 9200423, 6/30/2022; 9201209, 7/31/2022; 9204095, 7/31/2022; 9204283, 7/31/2022; 9206983, 7/31/2022; 9207534, 7/31/2022; 9207913, 7/31/2022; 9208099, 7/31/2022; 9211089, 7/31/2022; 9211677, 7/31/2022; 9212097, 7/31/2022; 9213911, 7/31/2022; 9214450, 7/31/2022; 9217995, 7/31/2022; 9218456, 7/31/2022; 9218466, 7/31/2022; 9220319, 7/31/2022; 9220320, 7/31/2022; 9222097, 7/31/2022; 9222098, 7/31/2022; 9222208, 7/31/2022; 9224704, 7/31/2022; 9225074, 7/31/2022; 9225081, 7/31/2022; 9226653, 7/31/2022; 9227526, 7/31/2022; 9227930, 7/31/2022; 9228303, 8/31/2022; 9232762, 8/31/2022; 9234176, 8/31/2022; 9234899, 8/31/2022; 9235837, 8/31/2022; 9236528, 8/31/2022; 9236529, 8/31/2022; 9238869, 8/31/2022; 9239631, 8/31/2022; 9239660, 8/31/2022; 9240736, 8/31/2022; 9241927, 8/31/2022; 9242195, 8/31/2022; 9243015, 8/31/2022; 9247747, 8/31/2022; 9248036, 8/31/2022; 9250289, 8/31/2022; 9250290, 8/31/2022; 9250395, 8/31/2022; 9255902, 8/31/2022; 9256126, 8/31/2022; 9259343, 8/31/2022; 9260247, 8/31/2022; 9260249, 9/30/2022; 9261887, 9/30/2022; 9262353, 9/30/2022; 9263126, 9/30/2022; 9264104, 9/30/2022; 9264107, 9/30/2022; 9266082, 9/30/2022; 9266337, 9/30/2022; 9267130, 9/30/2022; 9267132, 9/30/2022; 9268809, 9/30/2022; 9269989, 9/30/2022; 9269991, 9/30/2022; 9270898, 9/30/2022; 9271954, 9/30/2022; 9275594, 9/30/2022; 9276137, 9/30/2022; 9276159, 9/30/2022; 9278674, 9/30/2022; 9281274, 9/30/2022; 9282883, 9/30/2022; 9283393, 9/30/2022; 9287360, 9/30/2022; 9288429, 9/30/2022; 9289665, 9/30/2022; 9290448, 9/30/2022; 9293444, 10/31/2022; 9295579, 9/30/2022; 9296389, 10/31/2022; 9296399, 10/31/2022; 9297775, 10/31/2022; 9298637, 10/31/2022; 9298640, 10/31/2022; 9301749, 10/31/2022; 9301762, 10/31/2022; 9302581, 10/31/2022; 9302586, 10/31/2022; 9303414, 10/31/2022; 9303758, 10/31/2022; 9305773, 10/31/2022; 9309480, 10/31/2022; 9309567, 10/31/2022; 9311065, 10/31/2022; 9313838, 10/31/2022; 9313839, 10/31/2022; 9316341, 10/31/2022; 9317266, 11/30/2022; 9318804, 11/30/2022; 9318806, 11/30/2022; 9319143, 11/30/2022; 9320067, 11/30/2022; 9323280, 11/30/2022; 9323406, 11/30/2022; 9324538, 11/30/2022; 9324707, 11/30/2022; 9325125, 11/30/2022; 9327963, 11/30/2022; 9329366, 11/30/2022; 9329368, 11/30/2022; 9330598, 11/30/2022; 9331805, 11/30/2022; 9338115, 11/30/2022; 9338129, 11/30/2022; 9340890, 11/30/2022; 9343956, 11/30/2022; 9343958, 11/30/2022; 9344779, 11/30/2022; 9347277, 10/31/2022; 9351555, 12/31/2022; 9353728, 12/31/2022; 9354163, 12/31/2022; 9354165, 12/31/2022
Recall Number: D-0350-2021
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.
03-19-2021
05-05-2021
7,990,100 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.
Terminated
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
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.
09-29-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# 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
Recall Number: D-0346-2021
Microbial Contamination of Non-Sterile Product:.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.
03-19-2021
05-05-2021
6,869,400 cartons
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
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.
09-29-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# Lot and Exp Date: 0011737, 1/31/2023; 0020739, 1/31/2023; 0023790, 1/31/2023; 0037278, 1/31/2023; 0037279, 1/31/2023; 0038209, 1/31/2023; 0044734, 12/31/2022; 0007625, 10/31/2022; 0007630, 12/31/2022; 8095632, 3/31/2021; 8116723, 4/30/2021; 8127657, 4/30/2021; 8135651, 5/31/2021; 8137527, 5/31/2021; 8151741, 5/31/2021; 8158638, 5/31/2021; 8164530, 6/30/2021; 8178658, 6/30/2021; 8193779, 6/30/2021; 8197517, 6/30/2021; 8198765, 7/31/2021; 8212881, 7/31/2021; 8220737, 7/31/2021; 8226561, 7/31/2021; 8235991, 8/31/2021; 8249940, 8/31/2021; 8295569, 10/31/2021; 8304501, 10/31/2021; 8304849, 10/31/2021; 8306694, 10/31/2021; 8311791, 10/31/2021; 8334983, 11/30/2021; 8347719, 11/30/2021; 9008965, 12/31/2021; 9011841, 12/31/2021; 9031893, 1/31/2022; 9037824, 1/31/2022; 9038599, 1/31/2022; 9042938, 1/31/2022; 9044573, 1/31/2022; 9045831, 2/28/2022; 9051563, 2/28/2022; 9052565, 2/28/2022; 9053560, 2/28/2022; 9058847, 2/28/2022; 9059821, 2/28/2022; 9067665, 2/28/2022; 9072856, 2/28/2022; 9086532, 3/31/2022; 9087985, 3/31/2022; 9122538, 4/30/2022; 9126562, 4/30/2022; 9126564, 4/30/2022; 9137903, 5/31/2022; 9137904, 5/31/2022; 9154908, 5/31/2022; 9168975, 6/30/2022; 9171618, 6/30/2022; 9191256, 6/30/2022; 9218464, 7/31/2022; 9218595, 7/31/2022; 9221444, 7/31/2022; 9228305, 8/31/2022; 9241932, 8/31/2022; 9247742, 8/31/2022; 9249471, 8/31/2022; 9257903, 8/31/2022; 9263093, 9/30/2022; 9267133, 9/30/2022; 9269603, 9/30/2022; 9282881, 9/30/2022; 9284875, 9/30/2022; 9284881, 9/30/2022; 9289669, 9/30/2022; 9290455, 10/31/2022; 9291279, 10/31/2022; 9295914, 10/31/2022; 9296395, 10/31/2022; 9305775, 11/30/2022; 9311076, 2/28/2023; 9316348, 10/31/2022; 9317310, 11/30/2022; 9317312, 11/30/2022; 9324565, 11/30/2022; 9337530, 11/30/2022; 9341852, 11/30/2022; 9345911, 11/30/2022; 0098528, 12/31/2022
Recall Number: D-0345-2021
Microbial Contamination of Non-Sterile Product.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.
03-19-2021
05-05-2021
11,115,774 cartons
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
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.
09-29-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400
Batch or Lot Expiration Information
Lot# Lot and Exp Date: 0008777, 12/31/2022; 0016325, 12/31/2022; 0021072, 1/31/2023; 0027041, 1/31/2023; 0030959, 1/31/2023; 0031090, 1/31/2023; 0044735, 1/31/2023; 0048062, 2/28/2023; 0052110, 2/28/2023; 0056365, 2/28/2023; 0086148, 2/28/2023; 0104864, 3/31/2023; 0192894, 6/30/2023; 8081571, 3/31/2021; 8086851, 3/31/2021; 8087784, 3/31/2021; 8095620, 3/31/2021; 8106737, 4/30/2021; 8107819, 4/30/2021; 8124917, 4/30/2021; 8130509, 4/30/2021; 8131816, 4/30/2021; 8135646, 5/31/2021; 8141808, 5/31/2021; 8149992, 5/31/2021; 8155991, 5/31/2021; 8162912, 5/31/2021; 8163900, 5/31/2021; 8165721, 6/30/2021; 8176743, 6/30/2021; 8187644, 6/30/2021; 8194993, 6/30/2021; 8199884, 7/31/2021; 8201565, 7/31/2021; 8205560, 7/31/2021; 8206895, 7/31/2021; 8207995, 7/31/2021; 8221939, 7/31/2021; 8228634, 8/31/2021; 8235981, 8/31/2021; 8247508, 8/31/2021; 8264554, 9/30/2021; 8289654, 9/30/2021; 8299615, 10/31/2021; 8304783, 10/31/2021; 8311788, 10/31/2021; 8316776, 10/31/2021; 8332585, 11/30/2021; 8333924, 11/30/2021; 8337646, 11/30/2021; 8337647, 11/30/2021; 8338794, 11/30/2021; 8340914, 11/30/2021; 8352585, 12/31/2021; 8354835, 12/31/2021; 9007921, 12/31/2021; 9015917, 12/31/2021; 9015920, 12/31/2021; 9030934, 1/31/2022; 9043625, 1/31/2022; 9045819, 1/31/2022; 9046572, 2/28/2022; 9052554, 2/28/2022; 9059817, 2/28/2022; 9060734, 2/28/2022; 9071761, 2/28/2022; 9080812, 3/31/2022; 9087980, 3/31/2022; 9087982, 3/31/2022; 9088850, 3/31/2022; 9092575, 3/31/2022; 9100768, 3/31/2022; 9101529, 3/31/2022; 9105675, 3/31/2022; 9113528, 4/30/2022; 9123753, 4/30/2022; 9130718, 4/30/2022; 9133928, 4/30/2022; 9135816, 5/31/2022; 9149671, 5/31/2022; 9150905, 5/31/2022; 9154935, 5/31/2022; 9156866, 5/31/2022; 9165856, 5/31/2022; 9189224, 6/30/2022; 9194257, 6/30/2022; 9196196, 6/30/2022; 9198900, 6/30/2022; 9199815, 6/30/2022; 9200420, 6/30/2022; 9205441, 7/31/2022; 9206555, 7/31/2022; 9233323, 8/31/2022; 9233645, 8/31/2022; 9236531, 8/31/2022; 9238871, 8/31/2022; 9241929, 8/31/2022; 9242192, 8/31/2022; 9246940, 8/31/2022; 9246944, 8/31/2022; 9249460, 8/31/2022; 9251683, 8/31/2022; 9253785, 8/31/2022; 9254193, 8/31/2022; 9255899, 8/31/2022; 9257889, 8/31/2022; 9261886, 9/30/2022; 9266348, 9/30/2022; 9270894, 9/30/2022; 9278673, 9/30/2022; 9280666, 9/30/2022; 9284872, 9/30/2022; 9289666, 9/30/2022; 9291336, 10/31/2022; 9293445, 10/31/2022; 9295140, 10/31/2022; 9297772, 10/31/2022; 9304891, 10/31/2022; 9305777, 10/31/2022; 9311057, 10/31/2022; 9316346, 11/30/2022; 9325127, 11/30/2022; 9326162, 11/30/2022; 9331792, 11/30/2022; 9344775, 11/30/2022; 9345956, 11/30/2022; 9345958, 11/30/2022; 9350617, 12/31/2022; 9352330, 12/31/2022
Recall Number: D-0344-2021
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.
03-19-2021
05-05-2021
1,434,000 cartons
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
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.
09-29-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Recall Number: D-0343-2021
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.
03-19-2021
05-05-2021
952,100 cartons
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
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.
09-29-2022
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, 0.10 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
Recall Number: D-0348-2021
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.
03-19-2021
05-05-2021
14,275,400 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.
Terminated
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
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.
09-29-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Recall Number: D-0347-2021
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.
03-19-2021
05-05-2021
24,969,700 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.
Terminated
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
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.
09-29-2022
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, 0.10 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; 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