Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle,
Summary
The FDA issued a Class I for Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-sterile Solution, by Jarman's Midwest Cleaning Systems, Inc.. Reason: Chemical Contamination: FDA testing found Presence of methanol.
Details
Source
Drug Recall
External ID
D-0873-2023
Action Date
2023-06-21
Status
Terminated
Category
drug
Product Description
Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013.
Lot/Code Info: All batches labelled with Date of Manufacture (DOM): DOM 26MAR2020; DOM 01APR2020; DOM 02APR2020; DOM 27APR2020; DOM 04MAY2020; DOM 13MAY2020; DOM 04AUG2020.
Quantity Affected: 2365 gallons
Reason for Recall
Chemical Contamination: FDA testing found Presence of methanol
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-27
Company
Canton, SD
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 23 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Jarman's Midwest Cleaning Systems, Inc. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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 (Jarman's Midwest Cleaning Systems, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Jarman's Midwest Cleaning Systems, Inc. have FDA actions?
Jarman's Midwest Cleaning Systems, Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0873-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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