FDA-Drug2024-05-08Class III

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

Hazard

Out of specification for assay

Sold states
Nationwide within the United States
Affected count
15,414 units
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, 1 mL Single-Use vials, Rx only, 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-0478-2024

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