Recalls / Class III

Class IIID-0478-2024

Product

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

Affected lot / code info

Lot #: 23JUL028, Exp. Date 8/1/2024; 23AUG053, Exp. Date 8/30/2024

Why it was recalled

Out of specification for assay

Recalling firm

Firm

Imprimis NJOF, LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

1705 Route 46 Ste 6B, Ledgewood, New Jersey 07852-9720

Distribution

Quantity

15,414 units

Distribution pattern

Nationwide within the United States

Timeline

Recall initiated

2024-04-10

FDA classified

2024-04-30

Posted by FDA

2024-05-08

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0478-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.