Multi-event September 2020 FDA Recall Drug by Charles Paint Research Inc
This Multi-event Class II drug recall was voluntarily initiated by Charles Paint Research Inc on September 2, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Distributed in Michigan and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0791-2021
CGMP Deviations: Product manufactured in same facility where product was found to contain acetaldehyde and acetal above the allowable limits.
09-02-2020
09-15-2021
3,900 gallons
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Charles Paint Research Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed in Michigan
09-29-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution, Net weight (6 lbs 14.2 oz) 1 gallon; Net Quantity (3785 mL), Manufactured by Soapdaddy LLC, 2401 E. 85th Street, Kansas City, MO 64131
Batch or Lot Expiration Information
Lot# 20-151 to 20-159 and 20-161 to20-163, Exp 06/11/2022
Recall Number: D-0792-2021
CGMP Deviations: Product contains acetaldehyde and acetal above the allowable limits.
09-02-2020
09-15-2021
600 gallons
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Charles Paint Research Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed in Michigan
09-29-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution, Net weight (6 lbs 14.2 oz) 1 gallon; Net Quantity (3785 mL), Manufactured by Soapdaddy LLC, 2401 E. 85th Street, Kansas City, MO 64131
Batch or Lot Expiration Information
Lot# 20-160, Exp 06/11/2022
