Imprimis NJOF, LLC: Drug Recall

Recall #D-0040-2024 · 10/03/2023

Class III: Low Risk

Recall Details

Recall Number
D-0040-2024
Classification
Class III
Product Type
Drug
Recalling Firm
Imprimis NJOF, LLC
Status
Terminated
Date Initiated
10/03/2023
Location
Ledgewood, NJ, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
364 bags (1 mL filled in 2 mL glass amber vials; 20 vials shipped in a bag)

Reason for Recall

Subpotent: Failing Test Results for Epinephrine

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

Distribution Pattern

Nationwide

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.