FDA-Drug2024-06-05Class II

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

Hazard

Lack of Assurance of Sterility

Sold states
Nationwide within the United States
Affected count
165,920 vials
Manufactured in
1705 Route 46 Ste 6B, Ledgewood, NJ, United States
Products
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

Official notice

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

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