FindMyRecallSubscribe
Class II: temporary or reversible health riskOngoing

Seatex Alcohol Antiseptic 80% Topical Recall

Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution Net…

Seatex LLC · Rosenberg, TX

Risk level
Class II
Reported by FDA
May 10, 2023
Recall ID
D-0562-2023
Check your lot numberHow we source this data

Summary

Seatex recalled Seatex Alcohol Antiseptic 80% Topical starting Apr 19, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0562-2023 on May 10, 2023. Reason: Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications. Status: Ongoing.

Why it was recalled

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

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 numbers, UPCs & expiration codes

Lot: 220888, Exp. 05/20/2023

Where it was sold

FL, GA, TX

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0562-2023
Classification
Class II
Status
Ongoing
Recall initiated
Apr 19, 2023
FDA report date
May 10, 2023
Quantity
2880 containers
Recall type
Voluntary: Firm initiated
Recalling firm
Seatex LLC

Original FDA data

Every field from FDA enforcement report D-0562-2023, exactly as published.

Show all FDA fields
City
Rosenberg
State
TX
Status
Ongoing
Country
United States
Event ID
92164
Address
445 Highway 36 N
Code information
Lot: 220888, Exp. 05/20/2023
Postal code
77471-8756
Report date
May 10, 2023
Product type
Drugs
Recall number
D-0562-2023
Classification
Class II
Recalling firm
Seatex LLC
Product quantity
2880 containers
Reason for recall
Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
FL, GA, TX
Recall initiation date
Apr 19, 2023
Initial firm notification
Letter
Center classification date
May 3, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0562-2023, published May 10, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

Other recent drug recalls