Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand Sanitizer Non-sterile Solution, Volume: 3.785 L, plastic gallon
Summary
The FDA issued a Class II for Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand Sanitizer Non-sterile S by Jarman's Midwest Cleaning Systems, Inc.. Reason: CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products..
Details
Source
Drug Recall
External ID
D-0872-2023
Action Date
2023-06-21
Status
Terminated
Category
drug
Product Description
Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand Sanitizer Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013. NDC: 74663-002-01
Lot/Code Info: All batches labelled with Date of Manufacture (DOM): DOM 24MAR2020; DOM 12DEC2020.
Quantity Affected: 1276 gallons
Reason for Recall
CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-27
Company
Canton, SD
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 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 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 (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-0872-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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