Official recall notice
FDA DrugClass IINotable
FDA Recall: Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol
- Recall date
- 2026-07-29
- Category
- Drug
- FDA class
- Class II
Why it was recalled
Hazard
Lack of Assurance of Sterility
Product description
Lack of Assurance of Sterility
Affected products
Lot #: 3H1V, 3H1VA, Exp. Date 2025/07; 3J1V, 3J2V, Exp. Date 2025/09; 3K1V, Exp. Date 2025/10; 4F1V, Exp. Date 2027/05; 4F1VA, Exp. Date 2027/05; 4H1V, Exp. Date 2027/07; 4I1V, Exp. Date 2027/08; 4K1V, 4K2V,Exp. Date 2027/10; 5A1V, 5A2V, Exp. Date 2027/12; 5D1V, Exp. Date 2028/03; 5E1V, Exp. Date2028/04; 5J1V, 5J2V, Exp. Date 2028/09; 6B1V, Exp. Date 2029/01; 6C1V, 6C1VA, 6C1VB, Exp. Date 2029/02.