Recalls / Class II

Class IID-0512-2024

Product

Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-01

Affected lot / code info

Lot #: 23APR033, Exp. Date 5/1/24; 23JUN001, Exp. Date 6/5/24

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm

Imprimis NJOF, LLC

Type

Voluntary: Firm initiated

Address

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

Distribution

Quantity

14,180 vials

Distribution pattern

Nationwide within the United States

Timeline

Recall initiated

2024-05-14

FDA classified

2024-05-29

Posted by FDA

2024-06-05

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0512-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.