Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporat
Summary
The FDA issued a Class II for Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) p by Aire-Master of America Inc. Reason: CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization..
Details
Source
Drug Recall
External ID
D-1357-2022
Action Date
2022-08-24
Status
Terminated
Category
drug
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
Lot/Code Info: Product Number 46101, Lots 722712-exp 07/22, 724755-exp 11/22, 725054-exp 12/22
Quantity Affected: 4,632 cartons
Reason for Recall
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Distribution
Florida, Illinois, Iowa, New Jersey
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-15
Company
Nixa, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 61 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Aire-Master of America Inc has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aire-Master of America Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aire-Master of America Inc have FDA actions?
Aire-Master of America Inc has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1357-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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