Hand Sanitizer Recalled Due to Manufacturing Deficiency and Methanol Risk
Jarman's Midwest Cleaning Systems recalled 1,276 gallons of isopropyl alcohol hand sanitizer nationwide due to manufacturing deficiencies and potential methanol contamination risk found at the production site.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II classification with potential methanol contamination risk based on CGMP deficiencies at the manufacturing site. No illnesses or injuries have been reported, making this a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Jarman's Midwest Cleaning Systems, Inc. is recalling approximately 1,276 gallons of Isopropyl Alcohol Antiseptic 75%, a non-sterile topical hand sanitizer solution sold in 3.785 liter plastic gallon bottles. The product was distributed nationwide in the United States.
The recall is due to Current Good Manufacturing Practice (CGMP) deficiencies identified at the manufacturing facility. FDA testing detected the presence of methanol in other products manufactured at the same site, raising concerns about potential contamination risk in this product.
The affected batches are identified by their Date of Manufacture (DOM): DOM 24MAR2020 and DOM 12DEC2020. The product carries NDC 74663-002-01. Methanol is toxic if absorbed or ingested and could pose serious health risks if present.
The recalled product
- Product
- 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
- Manufacturer
- Jarman's Midwest Cleaning Systems, Inc.
- Hazard
- methanol-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All batches labelled with Date of Manufacture (DOM): DOM 24MAR2020
- DOM 12DEC2020.
Distribution
Distributed nationwide across the United States.
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