Seatex Alcohol Antiseptic 80% Hand Sanitizer Recalled for Superpotency and Impurities
Seatex Alcohol Antiseptic 80% (1-gallon containers) is being recalled because the formula does not meet specifications, with superpotency and impurities present. The recall affects lot 220888 distributed in Florida, Georgia, and Texas.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a topical antiseptic with confirmed formula deviations including superpotency and impurities. The product poses a risk of harm due to unknown impurities and deviation from labeled strength. Without reported hospitalizations or injuries, it does not meet the threshold for Severe (Score 4), but the documented quality failures and topical use context warrant High severity.
Plain-English summary
Seatex LLC is recalling Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer in 1-gallon (3.785 L) containers due to formula deviations. The product is being recalled because the formula does not adhere to labeled specifications.
The formula is superpotent (stronger than labeled) and contains impurities and degradation products that deviate from the product specification. These deviations mean the product does not meet the quality standards necessary for a topical antiseptic.
The recall affects lot 220888 (expiration date 05/20/2023) distributed to Florida, Georgia, and Texas, totaling approximately 2,880 containers. Consumers and healthcare facilities in these states should check their inventory and stop using affected product.
Consumers who have this product should not use it. If you have concerns about exposure, contact your healthcare provider. For more information, contact Seatex LLC at 445 TX Hwy 36, Rosenberg, TX 77471.
The recalled product
- 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.
- Manufacturer
- Seatex LLC
- Category
- Drug — Topical Antiseptic
- Affected units
- 2,880
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 220888
- Exp. 05/20/2023
Distribution
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