PlainRecalls
FDA Drug Low Class III Ongoing

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

Reported: May 8, 2024 Initiated: April 10, 2024 #D-0478-2024

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

Details

Recalling Firm
Imprimis NJOF, LLC
Units Affected
15,414 units
Distribution
Nationwide within the United States
Location
Ledgewood, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Imprimis NJOF, LLC. Units affected: 15,414 units.
Why was this product recalled?
Out of specification for assay
Which agency issued this recall?
This recall was issued by the FDA Drug on May 8, 2024. Severity: Low. Recall number: D-0478-2024.