Drug product
Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60693 USA. NDC: 53329-202-08, UPC 8 88277 34945 5
D-0458-2025
Product summary
- Event
- Event 96960
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 125,040 bottles
- Official record key
drug-enforcement:D-0458-2025
Official wording
Reason: Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
Code information: Lot, expiry: Lot 0644682, exp 2026/11/14; Lot 0644683, exp 2026/11/16
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Subpotent