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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87592

8 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 19, 2021
Product types
Drug
Classifications
Class I and Class II
Statuses
Terminated
Recalling firm wording
CareFusion 213, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

8 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 8

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-0343-2021
Recall number
D-0343-2021
Initiated
March 19, 2021
Classification
Class I
Status
Terminated
Recalling firm
CareFusion 213, LLC
Quantity
952,100 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for 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.

Code information

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;

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.

drug · product 2 of 8

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

D-0344-2021
Recall number
D-0344-2021
Initiated
March 19, 2021
Classification
Class I
Status
Terminated
Recalling firm
CareFusion 213, LLC
Quantity
1,434,000 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for 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.

Code information

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;

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.

drug · product 3 of 8

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

D-0345-2021
Recall number
D-0345-2021
Initiated
March 19, 2021
Classification
Class I
Status
Terminated
Recalling firm
CareFusion 213, LLC
Quantity
11,115,774 cartons

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Microbial Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

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;

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.

drug · product 4 of 8

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

D-0346-2021
Recall number
D-0346-2021
Initiated
March 19, 2021
Classification
Class I
Status
Terminated
Recalling firm
CareFusion 213, LLC
Quantity
6,869,400 cartons

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Microbial Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

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;

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.

drug · product 5 of 8

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
Recall number
D-0347-2021
Initiated
March 19, 2021
Classification
Class II
Status
Terminated
Recalling firm
CareFusion 213, LLC
Quantity
24,969,700 cartons

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

drug · product 6 of 8

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

D-0348-2021
Recall number
D-0348-2021
Initiated
March 19, 2021
Classification
Class II
Status
Terminated
Recalling firm
CareFusion 213, LLC
Quantity
14,275,400 cartons

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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: 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;

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.

drug · product 7 of 8

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

D-0349-2021
Recall number
D-0349-2021
Initiated
March 19, 2021
Classification
Class II
Status
Terminated
Recalling firm
CareFusion 213, LLC
Quantity
40,720,900 cartons

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

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;

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.

drug · product 8 of 8

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

D-0350-2021
Recall number
D-0350-2021
Initiated
March 19, 2021
Classification
Class II
Status
Terminated
Recalling firm
CareFusion 213, LLC
Quantity
7,990,100 cartons

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

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;

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.