Medications & Supplements/Prescription Drugs

Leiter's Enterprises, Inc.: Cefuroxime Intravitreal Injection Recalled for Incorrect Formulation

Agency Publication Date: March 6, 2019

Summary

Leiter's Enterprises, Inc. is recalling 569 vials of Cefuroxime (10 mg/mL) Intravitreal injection, a compounded sterile drug used for eye procedures. The product was incorrectly formulated using sterile water instead of the required 0.9% Sodium Chloride solution during reconstitution. This error affects one specific lot of 1 mL vials intended for ophthalmic and office use only. Patients who received this medication should contact their healthcare provider or pharmacist immediately, as the incorrect formulation can cause serious medical issues.

Risk

Injecting a drug reconstituted with sterile water instead of the proper saline solution (0.9% Sodium Chloride) can cause significant irritation, tissue damage, or other adverse reactions within the eye due to improper salt balance.

What You Should Do

Check your medical records or contact your healthcare provider to see if you received Cefuroxime 10 mg/mL in Sodium Chloride (Intravitreal injection) from Leiter's Enterprises, Inc.
Identify the affected product by looking for Lot # 1811195 with an expiration date of 05/01/19 and NDC 70360-007-35.
If you have this product in your possession, do not use it and contact the manufacturer, Leiter's Enterprises, Inc., at (800) 292-6772 for instructions on returning the vials.
Contact your healthcare provider or pharmacist immediately if you have received this injection and are experiencing any unusual symptoms or eye irritation.
Return any unused product to the pharmacy or place of purchase for a refund and contact the manufacturer for further guidance.
For additional questions or to report a problem, 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

Contact healthcare provider and return product for refund.

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

Affected Products

Product: Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection (1 mL in a 2mL Vial)

Model:

NDC: 70360-007-35

Recall #: D-0518-2019

Lot Numbers:

1811195 (Exp. Date: 05/01/19)

Date Ranges: 05/01/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82229

Status: Resolved

Manufacturer: Leiter's Enterprises, Inc.

Sold By: Leiter's Enterprises, Inc.

Manufactured In: United States

Units Affected: 569 vials

Distributed To: California, Arizona, Michigan, New York

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 records or contact your healthcare provider to see if you received Cefuroxime 10 mg/mL in Sodium Chloride (Intravitreal injection) from Leiter's Enterprises, Inc.

Identify the affected product by looking for Lot # 1811195 with an expiration date of 05/01/19 and NDC 70360-007-35.

If you have this product in your possession, do not use it and contact the manufacturer, Leiter's Enterprises, Inc., at (800) 292-6772 for instructions on returning the vials.

Contact your healthcare provider or pharmacist immediately if you have received this injection and are experiencing any unusual symptoms or eye irritation.

Return any unused product to the pharmacy or place of purchase for a refund and contact the manufacturer for further guidance.

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