FDAClass IIMay 5, 2021

BD ChloraPrep Clear recall: Sterility Concern

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…

Why was BD ChloraPrep Clear recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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;

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…
Recalling firm
CareFusion 213, LLC
Quantity
24,969,700 cartons
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.
Recall date
May 5, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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