FDA-Drug2022-02-02Class II
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
Edge Pharma, LLC
Hazard
Lack of Assurance of Sterility
Sold states
nationwide
Affected count
40 droptainers
Manufactured in
856 Hercules Dr, Colchester, VT, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0422-2022Don't want to check this manually?
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