Medications & Supplements/Prescription Drugs

Imprimis NJOF, LLC: Dexamethasone - Moxifloxacin PF Injection Recalled for Lack of Sterility

Agency Publication Date: December 30, 2020

Summary

Imprimis NJOF, LLC is recalling 6,520 vials of Dexamethasone - Moxifloxacin PF Injection (1/5 mg/mL) because 13 vials were found to have faulty crimps on the caps. This defect means the medication may not be sterile, which can lead to serious infections if injected into the eye or body. These prescription vials were sold nationwide in the United States and include lot 20JUN010 with an expiration date of May 12, 2021.

Risk

The faulty crimps on the medicine vials compromise the airtight seal, allowing bacteria or other contaminants to enter the product. If a non-sterile drug is injected into a patient, it can cause severe inflammation or sight-threatening infections.

What You Should Do

Check your medical supplies for 1mL vials of Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL manufactured by Imprimis NJOF, LLC.
Verify the lot number and expiration date on the vial label; this recall specifically affects Lot# 20JUN010 with an expiration date of 5/12/21.
Immediately stop using any vials from the affected lot and contact your healthcare provider or pharmacist for guidance on alternative treatments.
Return any unused vials to the pharmacy where they were purchased for a refund.
Contact Imprimis NJOF, LLC at (844) 446-6979 for further instructions regarding the return or disposal of the product.
For additional questions or to report a side effect, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx (1mL/vial)

Model:

D-0177-2021

Lot Numbers:

20JUN010 (Exp 5/12/21)

Date Ranges: Expires 5/12/21

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87029

Status: Resolved

Manufacturer: Imprimis NJOF, LLC

Sold By: hospitals; clinics; pharmacies

Manufactured In: United States

Units Affected: 6520 vials

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medical supplies for 1mL vials of Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL manufactured by Imprimis NJOF, LLC.

Verify the lot number and expiration date on the vial label; this recall specifically affects Lot# 20JUN010 with an expiration date of 5/12/21.

Immediately stop using any vials from the affected lot and contact your healthcare provider or pharmacist for guidance on alternative treatments.

Return any unused vials to the pharmacy where they were purchased for a refund.

Contact Imprimis NJOF, LLC at (844) 446-6979 for further instructions regarding the return or disposal of the product.

For additional questions or to report a side effect, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.