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
D-0872-2023
Product summary
- Event
- Event 92457
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1276 gallons
- Official record key
drug-enforcement:D-0872-2023
Official wording
Reason: CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.
Code information: All batches labelled with Date of Manufacture (DOM): DOM 24MAR2020; DOM 12DEC2020.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Presence of methanol
-
Manufacturing or process control
CGMP deficiencies