Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution Net Contents: 3.785 L (1 Gallon) Cont
Summary
The FDA issued a Class II for Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Soluti by Seatex LLC. Reason: Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications.
Details
Source
Drug Recall
External ID
D-0562-2023
Action Date
2023-05-10
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot: 220888, Exp. 05/20/2023
Quantity Affected: 2880 containers
Reason for Recall
Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications
Distribution
FL, GA, TX
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-19
Company
Rosenberg, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 45 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Seatex LLC has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Seatex LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Seatex LLC have FDA actions?
Seatex LLC has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0562-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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