D-0513-2024 Class II Ongoing

Recalled by Imprimis NJOF, LLC — Ledgewood, NJ

Recall Details

Product Type
Drugs
Report Date
June 5, 2024
Initiation Date
May 14, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
39,700 vials

Product Description

Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-512-01

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 23MAY016, Exp. Date 5/8/24; 23JUL016, Exp. Date 7/10/24; 23AUG034, Exp. Date 8/16/24; 23DEC014, Exp. Date 12/10/24