Multi-event September 2022 FDA Recall Drug by Salon Technologies International Inc

This Multi-event Class I drug recall was voluntarily initiated by Salon Technologies International Inc on September 14, 2022 for the product Drug. The FDA reported the reason for recall as chemical contamination. The product was distributed in FL and WA only and the recall is currently terminated.

Reported Recall Events

D-0002-2023 TERMINATED D-0001-2023 TERMINATED

Recall Number: D-0002-2023

Reason for Recall
Chemical Contamination: product found to contain benzene
Initiated
09-14-2022
Reported
10-12-2022
Quantity
512 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90874
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.
Salon Technologies International 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.
FL and WA only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-20-2024
Product Description About Product Description
Full technical description of the product.
Antica Farmacista Hand Sanitizer Ocean Citron (ethyl alcohol, denatured 65%) packaged in 473 mL/16 fl. oz. bottles, Dist. By Antica Farmacista Seattle, WA 98122 UPC 8 47005 00450 9

Batch or Lot Expiration Information

Lot# : 1166A Exp. 6/18/2023

Recall Number: D-0001-2023

Reason for Recall
GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Initiated
09-14-2022
Reported
10-12-2022
Quantity
1656 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90874
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.
Salon Technologies International 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.
FL and WA only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-20-2024
Product Description About Product Description
Full technical description of the product.
Sanitizing Hand Spray 80% (alcohol 80% v/v) Packaged in 2 FL OZ (60 mL) bottles, Salon Technologies International 8810 Commodity Circle STE 22-23, Orlando, FL 32819, UPC 6 96952 12904 5

Batch or Lot Expiration Information

Lot# : 20-018 Exp. 4/3/2023