Recalls / Class II

Class IID-0349-2021

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

Affected lot / code info: 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;

Why it was recalled

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.

Recalling firm

Firm: CareFusion 213, LLC
Notification channel: Press Release
Type: Voluntary: Firm initiated
Address: 1550 Northwestern Dr, N/A, El Paso, Texas 79912-8000

Distribution

Quantity: 40,720,900 cartons
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.

Timeline

Recall initiated: 2021-03-19
FDA classified: 2021-04-26
Posted by FDA: 2021-05-05
Terminated: 2022-09-29
Status: Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0349-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.