← FDA ENFORCEMENT
D-0513-2024Class II

Imprimis NJOF, LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Imprimis NJOF, LLC
Product type
Drug
Status
Ongoing
Report date
2024-06-05
Distribution
Nationwide within the United States
Firm state
NJ
Product quantity
39,700 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility

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

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →