Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx ...
FDA Recall #D-0478-2024 — Class III — April 10, 2024
Product Description
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
Reason for Recall
Out of specification for assay
Recalling Firm
Imprimis NJOF, LLC — Ledgewood, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
15,414 units
Distribution
Nationwide within the United States
Code Information
Lot #: 23JUL028, Exp. Date 8/1/2024; 23AUG053, Exp. Date 8/30/2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated