Medications & Supplements/Prescription Drugs

Imprimis NJOF Sterile Injectable Drugs Recalled for Lack of Sterility Assurance

Agency Publication Date: May 29, 2024

Summary

Imprimis NJOF, LLC has recalled approximately 276,840 vials of several sterile injectable medications, including Epinephrine-Lidocaine, Dexamethasone-Moxifloxacin, and Moxifloxacin, which are used primarily for eye surgeries. This voluntary recall was initiated because the company cannot guarantee the sterility of the products due to manufacturing issues. The affected drugs were distributed nationwide in various single-use vial sizes.

Risk

Medications injected into the eye must be completely sterile; if they are contaminated, they can cause serious eye infections or other severe complications. While no injuries have been reported to date, the lack of sterility assurance poses a significant safety risk to patients.

What You Should Do

This recall affects several preservative-free sterile injectable medications manufactured by Imprimis NJOF, LLC, including Epinephrine-Lidocaine HCl, Dexamethasone-Moxifloxacin, Dexamethasone-Moxifloxacin-Ketorolac, and two strengths of Moxifloxacin.
Identify affected products by checking the label for the manufacturer name 'Imprimis NJOF, LLC' and NDC numbers 71384-640-01, 71384-512-01, 71384-513-01, 71384-509-08, or 71384-511-08. See the Affected Products section below for the full list of affected codes.
Stop using the recalled product immediately.
Contact Imprimis NJOF, LLC or your distributor directly to arrange for the return of any remaining inventory.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free (1 mL)

Variants: Preservative-Free, Single-Use vial

Lot Numbers:

23APR033 (Exp. Date 5/1/24)

23JUN001 (Exp. Date 6/5/24)

NDC:

71384-640-01

Intraocular Injection

Product: Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free (1 mL)

Variants: Preservative-Free, Single-Use vial, Rx only

Lot Numbers:

23MAY016 (Exp. Date 5/8/24)

23JUL016 (Exp. Date 7/10/24)

23AUG034 (Exp. Date 8/16/24)

23DEC014 (Exp. Date 12/10/24)

NDC:

71384-512-01

Intraocular Injection

Product: Dexamethasone-Moxifloxacin-Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL) Preservative-Free (1 mL)

Variants: Preservative-Free, Single-Use vial, Rx only

Lot Numbers:

23MAY008 (Exp. Date 5/1/24)

23OCT011 (Exp. Date 10/26/24)

23NOV035 (Exp. Date 12/6/24)

24JAN024 (Exp. Date 1/14/25)

NDC:

71384-513-01

Intraocular Injection

Product: Moxifloxacin 0.8 mg/0.8 mL Preservative-Free (0.8 mL)

Variants: Preservative-Free, Single-Use vial, Rx only

Lot Numbers:

23OCT013 (Exp. Date 10/10/2024)

NDC:

71384-509-08

Intraocular Injection

Product: Moxifloxacin 4 mg/0.8 mL Preservative-Free (0.8 mL)

Variants: Preservative-Free, Single-Use vial, Rx only

Lot Numbers:

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)

NDC:

71384-511-08

Intraocular Injection

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94551

Status: Active

Manufacturer: Imprimis NJOF, LLC

Sold By: Hospitals; Surgical Centers; Clinics; Wholesalers

Manufactured In: United States

Units Affected: 5 products (14,180 vials; 39,700 vials; 38,060 vials; 18,980 vials; 165,920 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

This recall affects several preservative-free sterile injectable medications manufactured by Imprimis NJOF, LLC, including Epinephrine-Lidocaine HCl, Dexamethasone-Moxifloxacin, Dexamethasone-Moxifloxacin-Ketorolac, and two strengths of Moxifloxacin.

Identify affected products by checking the label for the manufacturer name 'Imprimis NJOF, LLC' and NDC numbers 71384-640-01, 71384-512-01, 71384-513-01, 71384-509-08, or 71384-511-08. See the Affected Products section below for the full list of affected codes.

Stop using the recalled product immediately.

Contact Imprimis NJOF, LLC or your distributor directly to arrange for the return of any remaining inventory.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for additional information.

Affected Products

Product: Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free (1 mL)

Variants: Preservative-Free, Single-Use vial

Lot Numbers:

23APR033 (Exp. Date 5/1/24)

23JUN001 (Exp. Date 6/5/24)

NDC:

71384-640-01

Intraocular Injection

Product: Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free (1 mL)

Variants: Preservative-Free, Single-Use vial, Rx only

Lot Numbers:

23MAY016 (Exp. Date 5/8/24)

23JUL016 (Exp. Date 7/10/24)

23AUG034 (Exp. Date 8/16/24)

23DEC014 (Exp. Date 12/10/24)

NDC:

71384-512-01

Intraocular Injection

Product: Dexamethasone-Moxifloxacin-Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL) Preservative-Free (1 mL)

Variants: Preservative-Free, Single-Use vial, Rx only

Lot Numbers:

23MAY008 (Exp. Date 5/1/24)

23OCT011 (Exp. Date 10/26/24)

23NOV035 (Exp. Date 12/6/24)

24JAN024 (Exp. Date 1/14/25)

NDC:

71384-513-01

Intraocular Injection

Product: Moxifloxacin 0.8 mg/0.8 mL Preservative-Free (0.8 mL)

Variants: Preservative-Free, Single-Use vial, Rx only

Lot Numbers:

23OCT013 (Exp. Date 10/10/2024)

NDC:

71384-509-08

Intraocular Injection

Product: Moxifloxacin 4 mg/0.8 mL Preservative-Free (0.8 mL)

Variants: Preservative-Free, Single-Use vial, Rx only

Lot Numbers:

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)

NDC:

71384-511-08

Intraocular Injection

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94551

Status: Active

Manufacturer: Imprimis NJOF, LLC

Sold By: Hospitals; Surgical Centers; Clinics; Wholesalers

Manufactured In: United States

Units Affected: 5 products (14,180 vials; 39,700 vials; 38,060 vials; 18,980 vials; 165,920 vials)

Distributed To: Nationwide