Edge Pharma, LLC recalls Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL
Recalled February 2, 2022 · FDA recall D-0421-2022 · Edge Pharma
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
2562 syringes
Sold at
nationwide
Description
Lack of Assurance of Sterility
Product
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe, Single Use Syringe, For Topical Ophthalmic Use, NDC 05446-0993-01
Manufacturer(s)
Edge Pharma, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →