Edge Pharma, LLC recalls Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.25%/ 0.25%/0.125%, 10 mL
Recalled February 2, 2022 · FDA recall D-0422-2022 · Edge Pharma
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
40 droptainers
Sold at
nationwide
Description
Lack of Assurance of Sterility
Product
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.25%/ 0.25%/0.125%, 10 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-0859-03
Manufacturer(s)
Edge Pharma, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →