FDA recall D-0872-2023

Jarman's Midwest Cleaning Systems, Inc. · Class II · drug

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

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

Key facts

Status: Terminated
Initiation date: 2023-03-27
Report date: 2023-06-21
Termination date: 2025-06-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Canton, SD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0872-2023