FDA Recall D-0562-2023

Seatex LLC · Rosenberg, TX

Class II Ongoing 1121 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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.

Lot / code: Lot: 220888, Exp. 05/20/2023

Quantity: 2880 containers

Reason for recall

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

Recall record

Recall number: D-0562-2023
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: FL, GA, TX
Recall initiated: 2023-04-19
Classified by FDA Center: 2023-05-03
FDA published: 2023-05-10
Recalling firm: Seatex LLC
Firm location: Rosenberg, TX

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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