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
Reason
Lack of Assurance of Sterility
Classification
Class II
Status
Terminated
Lot
09-2021-15@2 12/28/2021 & 11-2021-02@3 02/14/2022
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Edge Pharma, LLC — Class II Recall | MedicineWatch US