Why it was recalled
CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.
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 numbers, UPCs & expiration codes
All batches labelled with Date of Manufacture (DOM): DOM 24MAR2020; DOM 12DEC2020.
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0872-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 27, 2023
- FDA report date
- Jun 21, 2023
- Quantity
- 1276 gallons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jarman's Midwest Cleaning Systems, Inc.
Original FDA data
Every field from FDA enforcement report D-0872-2023, exactly as published.
Show all FDA fields
- City
- Canton
- State
- SD
- Status
- Terminated
- Country
- United States
- Event ID
- 92457
- Address
- 824 N Grant St
- Code information
- All batches labelled with Date of Manufacture (DOM): DOM 24MAR2020; DOM 12DEC2020.
- Postal code
- 57013-1357
- Report date
- Jun 21, 2023
- Product type
- Drugs
- Recall number
- D-0872-2023
- Classification
- Class II
- Recalling firm
- Jarman's Midwest Cleaning Systems, Inc.
- Product quantity
- 1276 gallons
- Termination date
- Jun 12, 2025
- Reason for recall
- CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 27, 2023
- Initial firm notification
- Letter
- Center classification date
- Jun 14, 2023