Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, N
Summary
The FDA issued a Class II for Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, R by Imprimis NJOF, LLC. Reason: Presence of particulate matter - Glass like particles..
Details
Source
Drug Recall
External ID
D-0249-2026
Action Date
2026-01-14
Status
Ongoing
Category
drug
Product Description
Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1
Lot/Code Info: Lot: 25MAY051, Expires: 06/26/2026; 25AUG003, Expires:08/07/2026
Quantity Affected: 778 boxes of 15,540 pre-filled syringes
Reason for Recall
Presence of particulate matter - Glass like particles.
Distribution
U.S Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-18
Company
Ledgewood, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 36 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Imprimis NJOF, LLC has 20 FDA actions in our database, including 20 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Imprimis NJOF, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Imprimis NJOF, LLC have FDA actions?
Imprimis NJOF, LLC has 20 FDA actions in our database, including 20 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0249-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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