Multi-event October 2018 FDA Recall Refresh Antibac Foam by S.c. Johnson Professional
This Multi-event Class II drug recall was voluntarily initiated by S.c. Johnson Professional on October 26, 2018 for the product Refresh Antibac Foam. The FDA reported the reason for recall as cgmp deviations. The product was distributed in NC and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0221-2019
CGMP Deviations: Product was released to market prior to microbiological testing.
10-26-2018
11-14-2018
258 cases
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.
S.C. Johnson Professional
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
NC
09-08-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Alcohol Free Foaming Hand Sanitizer (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Safe-T-Fresh Inc., USA, 2530 Xenium Lane North, Minneapolis, MN 55441.
Batch or Lot Expiration Information
Lot# Lot 9085
Recall Number: D-0220-2019
CGMP Deviations: Product was released to market prior to microbiological testing.
10-26-2018
11-14-2018
869 cases
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.
S.C. Johnson Professional
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
NC
09-08-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
deb stoko, Refresh AntiBac FOAM (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Made in the USA, Deb USA, Inc., Charlotte, NC 28217, NDC 11084-010-27.
Batch or Lot Expiration Information
Lot# Lot 9131
