FDA recall D-0535-2025

Imprimis NJOF, LLC · Class II · drug

Product

Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgewood, NJ, 07852 NDC: 71384-641-01

Reason for recall

Sub-Potent Drug: Subpotent assay results during stability testing.

Distribution

Nationwide in the USA

Key facts

Status: Completed
Initiation date: 2025-07-09
Report date: 2025-07-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Ledgewood, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0535-2025