Drug Enforcement D-0562-2023

Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications

Status

Ongoing

Classification

Class II

Report Date

May 10, 2023

Termination Date

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Product Information

Product description
Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution Net Contents: 3.785 L (1 Gallon) Container, UPC 6 12592 01480 0 Seatex, LLC. 445 TX Hwy 36 Rosenberg, TX 77471.
Product quantity
2880 containers
Reason for recall
Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
FL, GA, TX

Location & Firm

Recalling firm
Seatex LLC
Address
445 Highway 36 N

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0562-2023
Event ID
92164
Recall initiation date
April 19, 2023
Center classification date
May 3, 2023
Code info
Lot: 220888, Exp. 05/20/2023
More code info
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