Drug 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.
D-0562-2023
Product summary
- Firm
- Seatex LLC
- Event
- Event 92164
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2880 containers
- Official record key
drug-enforcement:D-0562-2023
Official wording
Reason: Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications
Code information: Lot: 220888, Exp. 05/20/2023
Distribution pattern: FL, GA, TX
Derived failure modes
-
Potency or specification failure
Superpotent