Multi-event March 2023 FDA Recall Drug by Jarman's Midwest Cleaning Systems, Inc.

This Multi-event Class II drug recall was voluntarily initiated by Jarman's Midwest Cleaning Systems, Inc. on March 27, 2023 for the product Drug. The FDA reported the reason for recall as cgmp deficiencies. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0872-2023 TERMINATED D-0874-2023 TERMINATED D-0873-2023 TERMINATED

Recall Number: D-0872-2023

Reason for Recall
CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.
Initiated
03-27-2023
Reported
06-21-2023
Quantity
1276 gallons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92457
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Jarman's Midwest Cleaning Systems, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-12-2025
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Batch# All batches labelled with Date of Manufacture (DOM): DOM 24MAR2020; DOM 12DEC2020.

Recall Number: D-0874-2023

Reason for Recall
Chemical Contamination: FDA testing found Presence of methanol
Initiated
03-27-2023
Reported
06-21-2023
Quantity
7303 gallons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92457
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Jarman's Midwest Cleaning Systems, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-12-2025
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 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.

Recall Number: D-0873-2023

Reason for Recall
Chemical Contamination: FDA testing found Presence of methanol
Initiated
03-27-2023
Reported
06-21-2023
Quantity
2365 gallons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92457
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Jarman's Midwest Cleaning Systems, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-12-2025
Product Description About Product Description
Full technical description of the product.
Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013.

Batch or Lot Expiration Information

Batch# All batches labelled with Date of Manufacture (DOM): DOM 26MAR2020; DOM 01APR2020; DOM 02APR2020; DOM 27APR2020; DOM 04MAY2020; DOM 13MAY2020; DOM 04AUG2020.