PlainRecalls
FDA Drug Low Class III Terminated

Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01 Not for resale. Office use only. Lot: 23APR018 Date Compounded: 24APR2023 Expires on: 17APR2024. In case of adverse event contact: www.fda.gov/medwatch or (800)-FDA-1088 Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852 (844) 446-6979

Reported: October 11, 2023 Initiated: October 3, 2023 #D-0040-2024

Product Description

Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01 Not for resale. Office use only. Lot: 23APR018 Date Compounded: 24APR2023 Expires on: 17APR2024. In case of adverse event contact: www.fda.gov/medwatch or (800)-FDA-1088 Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852 (844) 446-6979

Reason for Recall

Subpotent: Failing Test Results for Epinephrine

Details

Recalling Firm
Imprimis NJOF, LLC
Units Affected
364 bags (1 mL filled in 2 mL glass amber vials; 20 vials shipped in a bag)
Distribution
Nationwide
Location
Ledgewood, NJ

Frequently Asked Questions

What product was recalled?
Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01 Not for resale. Office use only. Lot: 23APR018 Date Compounded: 24APR2023 Expires on: 17APR2024. In case of adverse event contact: www.fda.gov/medwatch or (800)-FDA-1088 Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852 (844) 446-6979. Recalled by Imprimis NJOF, LLC. Units affected: 364 bags (1 mL filled in 2 mL glass amber vials; 20 vials shipped in a bag).
Why was this product recalled?
Subpotent: Failing Test Results for Epinephrine
Which agency issued this recall?
This recall was issued by the FDA Drug on October 11, 2023. Severity: Low. Recall number: D-0040-2024.