Multi-event October 2021 FDA Recall Drug by Virgin Scent Inc
This Multi-event Class II drug recall was voluntarily initiated by Virgin Scent Inc on October 26, 2021 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0783-2022
CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot
10-26-2021
04-27-2022
570,268 Bottles
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.
VIRGIN SCENT 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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the U.S.A
07-31-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 fl oz (236 ml) bottles, Dist. By artnaturals, Gardena, CA 90248, UPC: 8 16820 02820 5
Batch or Lot Expiration Information
Lot# Lot: G20109D, G2019E, G20125E, G20125F, G20125D, G20125A, G20126C, G20126A, G20126D, G20126B, G20126E, G20127C, G20127B, G20127D, G20127A, G20127F, G20127A, G20128B, G20128C, G20128D, G20128E, G20128F, G20129B, G20129A, G20129C, G20129D, G20129E, G20130B, G20130A, G20130C, G20132A, G20132B, G20133A, EXP 5/1/2022; G20133A, EXP 8/1/2022
Recall Number: D-0784-2022
CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot
10-26-2021
04-27-2022
46,368 Bottles
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.
VIRGIN SCENT 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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the U.S.A
07-31-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
artnaturals Hand Sanitizer
Batch or Lot Expiration Information
Lot# Lot: G20154A, G20155A, EXP 6/1/2022
Recall Number: D-0782-2022
Chemical Contamination: presence of benzene, acetaldehyde, and acetal.
10-26-2021
04-27-2022
47,832 bottles
Recall Profile & Regulatory Data
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.
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.
VIRGIN SCENT 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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the U.S.A
07-31-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 fl oz (236 ml) bottles, Dist. By artnaturals, Gardena, CA 90248, UPC: 8 16820 02820 5
Batch or Lot Expiration Information
Lot# Lot: G20127E, G20128A, EXP 5/1/2022
