D-0040-2024 Class III Terminated

Recalled by Imprimis NJOF, LLC — Ledgewood, NJ

Recall Details

Product Type
Drugs
Report Date
October 11, 2023
Initiation Date
October 3, 2023
Termination Date
March 21, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
364 bags (1 mL filled in 2 mL glass amber vials; 20 vials shipped in a bag)

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

Distribution Pattern

Nationwide

Code Information

23APR018