FDA recall D-0422-2022

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

Reason for recall

Lack of Assurance of Sterility

Distribution

nationwide

Key facts

Status

Terminated

Initiation date

2021-12-06

Report date

2022-02-02

Termination date

2023-06-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Colchester, VT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0422-2022