Medications & Supplements/Prescription Drugs

Heritage Pharmaceuticals, Inc.: Cidofovir Injection Recalled Due to Lack of Sterility Assurance

Agency Publication Date: January 8, 2019

Summary

Heritage Pharmaceuticals, Inc. has recalled 5,060 units of Cidofovir Injection 375mg/5mL (75mg/mL) due to concerns that the vials may not be sterile. The recall was triggered by complaints of dried powder found on the outside of the vials, which indicates the containers may not have maintained a proper seal. If you have this medication, contact your healthcare provider or pharmacist immediately to discuss your treatment and return any unused product to the place of purchase for a refund.

Risk

A lack of sterility assurance in an injectable medication means the product could be contaminated with bacteria or other microorganisms. Injecting a non-sterile drug directly into the body can lead to serious, potentially life-threatening systemic infections.

What You Should Do

Check your medication vials to see if you have Cidofovir Injection 375mg/5mL (75mg/mL) with NDC 23155-0216-31.
Verify the lot numbers and expiration dates on the packaging: look for lot VCIA082 (Expiration May 2020), or lots VCIA083 and VCIA084 (Expiration June 2020).
If you have an affected product, contact your healthcare provider or pharmacist immediately for guidance and to arrange for a replacement treatment.
Return any unused vials to the pharmacy or place of purchase to receive a full refund.
Contact Heritage Pharmaceuticals, Inc. at their East Brunswick, NJ office for further instructions regarding the return process.
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

Refund for unused product

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

Affected Products

Product: Cidofovir Injection 375mg/5mL (75mg/mL)

Model:

NDC 23155-0216-31

Lot Numbers:

VCIA082 (Exp. MAY 2020)

VCIA083 (Exp. JUNE 2020)

VCIA084 (Exp. JUNE 2020)

Date Ranges: MAY 2020, JUNE 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81896

Status: Resolved

Manufacturer: Heritage Pharmaceuticals, Inc.

Sold By: pharmacies; hospitals; clinics

Manufactured In: India, United States

Units Affected: 5,060 units

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 medication vials to see if you have Cidofovir Injection 375mg/5mL (75mg/mL) with NDC 23155-0216-31.

Verify the lot numbers and expiration dates on the packaging: look for lot VCIA082 (Expiration May 2020), or lots VCIA083 and VCIA084 (Expiration June 2020).

If you have an affected product, contact your healthcare provider or pharmacist immediately for guidance and to arrange for a replacement treatment.

Return any unused vials to the pharmacy or place of purchase to receive a full refund.

Contact Heritage Pharmaceuticals, Inc. at their East Brunswick, NJ office for further instructions regarding the return process.

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.