FDA recall D-0516-2024

Product

Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-511-08

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide within the United States

Key facts

Status

Ongoing

Initiation date

2024-05-14

Report date

2024-06-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ledgewood, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0516-2024