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Recall Observatory FDA recall evidence

Drug 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

D-0347-2021

March 19, 2021

Class II

Product summary

Firm
CareFusion 213, LLC
Event
Event 87592
Status
Terminated
Classification
Class II
Quantity
24,969,700 cartons
Official record key
drug-enforcement:D-0347-2021

Official wording

Reason: 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.

Code information: 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;

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.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility