FDA-Drug2022-02-02Class II
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
Edge Pharma, LLC
Hazard
Lack of Assurance of Sterility
Sold states
nationwide
Affected count
2562 syringes
Manufactured in
856 Hercules Dr, Colchester, VT, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0421-2022Don't want to check this manually?
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