Recall Enforment Report D-1357-2022

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Aire-Master of America Inc, originally initiated on 07-15-2022 for the product Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440 The product was recalled due to cgmp deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.. The product was distributed in Florida, Illinois, Iowa, New Jersey and the recall is currently terminated.

Recall Enforcement Reports

Recall Number	Recall Initiation Date	Report Date	Recall Classification	Quantity	Product Description	Recall Reason	Status
D-1357-2022	07-15-2022	08-24-2022	Class II	4,632 cartons	Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440	CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.	Terminated
D-1355-2022	07-15-2022	08-24-2022	Class II	18 oz bottle: 11,435 bottles; 1000 mL pouch: 4,116 pouches, c) 2 drums	Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL (33.9 fl. oz.) pouch, c) 55 gallon drum, Fragrance Free, Manufactured for B4 Brands, Lisbon, Iowa 62253	CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.	Terminated
D-1358-2022	07-15-2022	08-24-2022	Class II	960 cartons	Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.	CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.	Terminated
D-1359-2022	07-15-2022	08-24-2022	Class II	5,064 bottles	Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa, FL 33606	CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.	Terminated
D-1360-2022	07-15-2022	08-24-2022	Class II	4 totes	Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka Harbor, NJ 08734	CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.	Terminated
D-1356-2022	07-15-2022	08-24-2022	Class II	9,176 cartons	Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa 52253	CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.	Terminated

Field Name	Field Value
Event ID	90644 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1357-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	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 What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Florida, Illinois, Iowa, New Jersey What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440
Reason For Recall	CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	4,632 cartons Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	08-24-2022
Recall Initiation Date	07-15-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	02-19-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Aire-Master of America Inc
Code Info	Product Number 46101, Lots 722712-exp 07/22, 724755-exp 11/22, 725054-exp 12/22 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	90644 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1355-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	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 What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Florida, Illinois, Iowa, New Jersey What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL (33.9 fl. oz.) pouch, c) 55 gallon drum, Fragrance Free, Manufactured for B4 Brands, Lisbon, Iowa 62253
Reason For Recall	CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	18 oz bottle: 11,435 bottles; 1000 mL pouch: 4,116 pouches, c) 2 drums Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	08-24-2022
Recall Initiation Date	07-15-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	02-19-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Aire-Master of America Inc
Code Info	[Product number], lot code, expiry: a) [46016] Lot 722770, exp 07/22 b) [46017] Lot 722995-exp 07/22, 727370-exp 07/23, 727898-exp 09/23, 728005-exp 08/23, 729522-exp12/23, 730412-exp 03/24, 730861-exp 04/24 c) [46138] Lot 725188-exp 12/22 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	90644 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1358-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	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 What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Florida, Illinois, Iowa, New Jersey What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.
Reason For Recall	CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	960 cartons Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	08-24-2022
Recall Initiation Date	07-15-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	02-19-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Aire-Master of America Inc
Code Info	Product Number 46112, Lots 722782 -exp 08/22 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	90644 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1359-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	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 What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Florida, Illinois, Iowa, New Jersey What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa, FL 33606
Reason For Recall	CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	5,064 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	08-24-2022
Recall Initiation Date	07-15-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	02-19-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Aire-Master of America Inc
Code Info	Product Number 46111, Lot 722781-exp 09/22 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	90644 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1360-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	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 What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Florida, Illinois, Iowa, New Jersey What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka Harbor, NJ 08734
Reason For Recall	CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	4 totes Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	08-24-2022
Recall Initiation Date	07-15-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	02-19-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Aire-Master of America Inc
Code Info	Product Number 46137, Lot 724640-exp 11/22, 729955-exp 01/24 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	90644 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1356-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	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 What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Florida, Illinois, Iowa, New Jersey What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa 52253
Reason For Recall	CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	9,176 cartons Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	08-24-2022
Recall Initiation Date	07-15-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	02-19-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Aire-Master of America Inc
Code Info	Product Number 46076 Lot 722896-exp 07/22, 722996-exp 07/22 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.