FDA-Drug2024-06-05Class II

Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-01

Hazard

Lack of Assurance of Sterility

Sold states
Nationwide within the United States
Affected count
14,180 vials
Manufactured in
1705 Route 46 Ste 6B, Ledgewood, NJ, United States
Products
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0512-2024

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