Drug product
SOFT HANDS Alcohol Antiseptic 80%, Topical Solution, HAND SANITIZER, NON-STERILE SOLUTION, cleanpro SUPPLY, 1 US gallon / 3785.41ml, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013.
D-0874-2023
Product summary
- Event
- Event 92457
- Status
- Terminated
- Classification
- Class I
- Quantity
- 7303 gallons
- Official record key
drug-enforcement:D-0874-2023
Official wording
Reason: Chemical Contamination: FDA testing found Presence of methanol
Code information: All product labelled with Date of Manufacture (DOM): DOM 26MAR2020; DOM 01APR2020; DOM 02APR2020; DOM 04APR2020; DOM 27APR2020; DOM 04MAY2020; DOM 07MAY2020; DOM 13MAY2020; DOM 04AUG2020.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination