Drug product
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only. Not for IV Use. Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67226. NDC: 71266-8240-01
D-0221-2026
Product summary
- Event
- Event 98040
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2980 syringes
- Official record key
drug-enforcement:D-0221-2026
Official wording
Reason: Incorrect Product Formulation
Code information: Lot#: C274-000047958; Exp. December 19, 2025
Distribution pattern: U.S. Nationwide.
Derived failure modes
-
Unknown
Incorrect Product Formulation