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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90644

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

Open FDA event record

Event summary

Timeline bucket
July 15, 2022
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Aire-Master of America Inc

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

6 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 6

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

D-1355-2022
Recall number
D-1355-2022
Initiated
July 15, 2022
Classification
Class II
Status
Terminated
Quantity
18 oz bottle: 11,435 bottles; 1000 mL pouch: 4,116 pouches, c) 2 drums

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 manufactured using deionized water from a system lacking appropriate microbial control post deionization.

Code information

[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

Distribution pattern

Florida, Illinois, Iowa, New Jersey

drug · product 2 of 6

Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa 52253

D-1356-2022
Recall number
D-1356-2022
Initiated
July 15, 2022
Classification
Class II
Status
Terminated
Quantity
9,176 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 manufactured using deionized water from a system lacking appropriate microbial control post deionization.

Code information

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

Distribution pattern

Florida, Illinois, Iowa, New Jersey

drug · product 3 of 6

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

D-1357-2022
Recall number
D-1357-2022
Initiated
July 15, 2022
Classification
Class II
Status
Terminated
Quantity
4,632 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 manufactured using deionized water from a system lacking appropriate microbial control post deionization.

Code information

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

Distribution pattern

Florida, Illinois, Iowa, New Jersey

drug · product 4 of 6

Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.

D-1358-2022
Recall number
D-1358-2022
Initiated
July 15, 2022
Classification
Class II
Status
Terminated
Quantity
960 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 manufactured using deionized water from a system lacking appropriate microbial control post deionization.

Code information

Product Number 46112, Lots 722782 -exp 08/22

Distribution pattern

Florida, Illinois, Iowa, New Jersey

drug · product 5 of 6

Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa, FL 33606

D-1359-2022
Recall number
D-1359-2022
Initiated
July 15, 2022
Classification
Class II
Status
Terminated
Quantity
5,064 bottles

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 manufactured using deionized water from a system lacking appropriate microbial control post deionization.

Code information

Product Number 46111, Lot 722781-exp 09/22

Distribution pattern

Florida, Illinois, Iowa, New Jersey

drug · product 6 of 6

Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka Harbor, NJ 08734

D-1360-2022
Recall number
D-1360-2022
Initiated
July 15, 2022
Classification
Class II
Status
Terminated
Quantity
4 totes

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 manufactured using deionized water from a system lacking appropriate microbial control post deionization.

Code information

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

Distribution pattern

Florida, Illinois, Iowa, New Jersey