Stop using now Drug recall · FDA · Published May 14, 2024

Imprimis Recalls Sterile Eye Vials Due to Sterility Risk

Imprimis NJOF recalls 38,060 vials of Dexamethasone-Moxifloxacin-Ketorolac due to lack of sterility assurance. Check lot numbers and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0514-2024Drug Imprimis NJOF ›

Stop using this now

Lack of Assurance of Sterility

Take action

Contact the company

Recalling firmImprimis NJOF, LLC1705 Route 46 Ste 6B · Ledgewood, NJ 07852-9720

✎ GovInfoNow plain-language explainer

Imprimis NJOF, LLC is recalling specific lots of preservative-free Dexamethasone-Moxifloxacin-Ketorolac vials intended for intraocular injection. The recall is necessary because there is a lack of assurance that the product remains sterile during manufacturing or storage. Using non-sterile eye medications can lead to serious eye infections. Read more at govinfonow.com/recall/32670-imprimis-recalls-sterile-eye-vials-due-to-sterility-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/32670-imprimis-recalls-sterile-eye-vials-due-to-sterility-risk · Updated October 9, 2026 · FDA enforcement record: FDA #D-0514-2024

Cite this page

“Imprimis Recalls Sterile Eye Vials Due to Sterility Risk.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32670-imprimis-recalls-sterile-eye-vials-due-to-sterility-risk. Based on FDA recall #D-0514-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0514-2024%22&limit=1).

Imprimis NJOF, LLC recalled Dexamethasone-Moxifloxacin-Ketorolac vials due to a lack of assurance of sterility, according to the FDA on May 14, 2024. The recall affects 38,060 units distributed nationwide.

How to tell if you have it

Brand: Imprimis NJOF
Product: Dexamethasone-Moxifloxacin-Ketorolac Vials
NDC: 71384-513-01
Lot codes: 23MAY008, 23OCT011, 23NOV035, 24JAN024
Expiration dates: 5/1/24, 10/26/24, 12/6/24, 1/14/25

The hazard

The product poses a risk due to a lack of assurance of sterility.

Context

GovInfoNow's records show Imprimis NJOF, LLC has 13 other recalls on record since Dec. 17, 2020. Other recent recalls of similar products include Clear Eyes Eye Drops Recalled for Sterility Risk (July 29, 2026) and K.C. Pharmaceuticals Recalls Sterile Eye Drops Due to Lack of Sterility Assurance (March 3, 2026).

How to tell if you have this one

Look for 1mL single-use vials labeled 'Dexamethasone-Moxifloxacin-Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free'. Check the NDC 71384-513-01 and verify if your lot number is one of the following: 23MAY008 (Exp. 5/1/24), 23OCT011 (Exp. 10/26/24), 23NOV035 (Exp. 12/6/24), or 24JAN024 (Exp. 1/14/25).

Brand
Imprimis NJOF
Category
Drug

FDA recall event · 5 products

All 5 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide within the United States

Recall number	Product, codes & lots	Quantity
D-0512-2024	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; Lot #: 23APR033, Exp. Date 5/1/24; 23JUN001, Exp. Date 6/5/24	14,180 vials
D-0513-2024	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; 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	39,700 vials
D-0514-2024	Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/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 71384-513-01; Lot #: 23MAY008, Exp. Date 5/1/24; 23OCT011, Exp. Date 10/26/24; 23NOV035, Exp. Date 12/6/24; 24JAN024, Exp. Date 1/14/25	38,060 vials
D-0515-2024	Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-509-08; Lot #: 23OCT013, Exp. Date 10/10/2024	18,980 vials
D-0516-2024	Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-511-08; Lot #: 23JUN003, Exp. Date 5/29/2024; 23JUL035, Exp. Date 7/24/2024; 23AUG033, Exp. Date 8/14/2024; 23AUG043, Exp. Date 8/21/2024; 23SEP001, Exp. Date 9/26/2024; 23OCT002, Exp. Date 10/4/2024; 23OCT031, Exp. Date 10/31/2024; 23NOV011, Exp. Date 11/28/2024; 24FEB027, Exp. Date 2/15/2025	165,920 vials

Based on the official FDA remedy

What to do — step by step

Stop Using the Vials
Do not use any vials matching the recalled lot numbers for intraocular injection.
Contact Your Healthcare Provider
Inform your doctor or pharmacist about the recall to discuss alternative treatments or proper disposal methods.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 22 days after the firm started it.

May 14, 2024Firm started the recall
May 29, 2024FDA classified it Class II
Jun 5, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What is the specific hazard with these vials?

The recall is due to a lack of assurance of sterility, meaning the vials may not be free from microorganisms.

Where were these products distributed?

The recalled vials were distributed nationwide within the United States.

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/32670-imprimis-recalls-sterile-eye-vials-due-to-sterility-risk">Imprimis Recalls Sterile Eye Vials Due to Sterility Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0514-2024 (May 14, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0514-2024 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.