FDA recall D-0548-2024

Product

Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ NDC 71384-310-05

Reason for recall

Lack of Assurance of Sterility

Distribution

US Nationwide

Key facts

Status

Ongoing

Initiation date

2024-05-14

Report date

2024-06-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ledgewood, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0548-2024