Drug product
Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 Development Avenue, Chambersburg, PA 17210, Toll Free: 800-345-1329, Package Configurations: a) 6x1000mL Case, b) 4x1 Gallon Case, c) 5 Gallon Pail, d) 55 Gallon Drum.
D-0004-2026
Product summary
- Event
- Event 97688
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0004-2026
Official wording
Reason: cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
Code information: Lot # C2427010, Exp 9/26/2025; Lot # C2432621, Exp 11/21/2025; Lot # C2501514, Exp 1/15/2026; Lot # C2508606, Exp 3/27/2026.
Distribution pattern: US Nationwide.
Derived failure modes
-
Manufacturing or process control
cGMP deviations