FDA-Drug2024-06-05Class II
Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01
Imprimis NJOF, LLC
Hazard
Lack of Assurance of Sterility
Sold states
Nationwide within the United States
Affected count
38,060 vials
Manufactured in
1705 Route 46 Ste 6B, Ledgewood, NJ, United States
Products
Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0514-2024Don't want to check this manually?
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