Drug Enforcement D-0001-2023

GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

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Status

Terminated

Classification

Class II

Report Date

October 12, 2022

Termination Date

August 20, 2024

Product Information

Product description
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
Product quantity
1656 bottles
Reason for recall
GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
FL and WA only

Location & Firm

Recalling firm
Salon Technologies International Inc
Address
8810 Commodity Cir Ste 20, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0001-2023
Event ID
90874
Recall initiation date
September 14, 2022
Center classification date
October 4, 2022
Code info
Lot #: 20-018 Exp. 4/3/2023
More code info