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Recall Observatory FDA recall evidence

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

March 27, 2023

Class I

Product summary

Firm
Jarman's Midwest Cleaning Systems, Inc.
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

    reason.foreign_material_chemical_contamination · v1.0.0

    Chemical Contamination