Multi-event July 2022 FDA Recall Drug by Aire-master Of America Inc

This Multi-event Class II drug recall was voluntarily initiated by Aire-master Of America Inc on July 15, 2022 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Florida, Illinois, Iowa, New Jersey and the recall is currently terminated.

Reported Recall Events

D-1358-2022 TERMINATED D-1357-2022 TERMINATED D-1355-2022 TERMINATED D-1360-2022 TERMINATED D-1356-2022 TERMINATED D-1359-2022 TERMINATED

Recall Number: D-1358-2022

Reason for Recall
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Initiated
07-15-2022
Reported
08-24-2022
Quantity
960 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90644
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Aire-Master of America Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Florida, Illinois, Iowa, New Jersey
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2023
Product Description About Product Description
Full technical description of the product.
Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.

Batch or Lot Expiration Information

Lot# Product Number 46112, Lots 722782 -exp 08/22

Recall Number: D-1357-2022

Reason for Recall
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Initiated
07-15-2022
Reported
08-24-2022
Quantity
4,632 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90644
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Aire-Master of America Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Florida, Illinois, Iowa, New Jersey
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2023
Product Description About Product Description
Full technical description of 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

Batch or Lot Expiration Information

Lot# Product Number 46101, Lots 722712-exp 07/22, 724755-exp 11/22, 725054-exp 12/22

Recall Number: D-1355-2022

Reason for Recall
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Initiated
07-15-2022
Reported
08-24-2022
Quantity
18 oz bottle: 11,435 bottles; 1000 mL pouch: 4,116 pouches, c) 2 drums

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90644
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Aire-Master of America Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Florida, Illinois, Iowa, New Jersey
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2023
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# [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

Recall Number: D-1360-2022

Reason for Recall
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Initiated
07-15-2022
Reported
08-24-2022
Quantity
4 totes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90644
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Aire-Master of America Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Florida, Illinois, Iowa, New Jersey
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2023
Product Description About Product Description
Full technical description of the product.
Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka Harbor, NJ 08734

Batch or Lot Expiration Information

Lot# Product Number 46137, Lot 724640-exp 11/22, 729955-exp 01/24

Recall Number: D-1356-2022

Reason for Recall
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Initiated
07-15-2022
Reported
08-24-2022
Quantity
9,176 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90644
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Aire-Master of America Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Florida, Illinois, Iowa, New Jersey
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2023
Product Description About Product Description
Full technical description of the product.
Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa 52253

Batch or Lot Expiration Information

Lot# Product Number 46076 Lot 722896-exp 07/22, 722996-exp 07/22

Recall Number: D-1359-2022

Reason for Recall
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Initiated
07-15-2022
Reported
08-24-2022
Quantity
5,064 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90644
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Aire-Master of America Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Florida, Illinois, Iowa, New Jersey
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2023
Product Description About Product Description
Full technical description of the product.
Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa, FL 33606

Batch or Lot Expiration Information

Lot# Product Number 46111, Lot 722781-exp 09/22