Status
Terminated
Drug Enforcement D-0872-2023
CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.
Classification
Class II
Report Date
June 21, 2023
Termination Date
June 12, 2025
Product Information
- 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
- Product quantity
- 1276 gallons
- Reason for recall
- CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Jarman's Midwest Cleaning Systems, Inc.
- Address
-
824 N Grant St, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0872-2023
- Event ID
- 92457
- Recall initiation date
- March 27, 2023
- Center classification date
- June 14, 2023
- Code info
- All batches labelled with Date of Manufacture (DOM): DOM 24MAR2020; DOM 12DEC2020.
- More code info
- —