Medications & Supplements/Prescription Drugs

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

Agency Publication Date: October 24, 2018

Summary

Heritage Pharmaceuticals, Inc. is recalling 2,789 units of Cidofovir injection 375 mg/mL (75 mg/mL) in 5 mL vials due to a lack of sterility assurance. The recall was initiated after receiving complaints about dried powder on the outside of the bottles, which indicates potential leakage or contamination. Consumers should contact their healthcare provider or pharmacist regarding any use of this product and return unused vials for a refund.

Risk

A lack of sterility assurance in an injectable medication means the product may be contaminated with bacteria or other pathogens. If a non-sterile drug is injected, it can cause serious, life-threatening infections or other severe medical complications.

What You Should Do

Check your medication vials for Cidofovir injection 375 mg/mL (75 mg/mL) in 5 mL vials with UPC 323155216388 and NDC 23155-216-31.
Specifically look for lot number VCIA083 with an expiration date of JUN2020 printed on the label.
Stop using any vials from the affected lot immediately and contact your healthcare provider or pharmacist for guidance on alternative treatments.
Return any unused product from the affected lot to the place of purchase or pharmacy for a refund.
Contact Heritage Pharmaceuticals, Inc. for further instructions regarding the return process.
For additional questions, 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 guidance and product refund

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 375 mg/mL (75 mg/mL) (5 mL vials)

Model:

NDC 23155-216-31

UPC Codes:

323155216388

Lot Numbers:

VCIA083 (Exp. JUN2020)

Date Ranges: JUN2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81276

Status: Resolved

Manufacturer: Heritage Pharmaceuticals, Inc.

Manufactured In: India, United States

Units Affected: 2,789 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 for Cidofovir injection 375 mg/mL (75 mg/mL) in 5 mL vials with UPC 323155216388 and NDC 23155-216-31.

Specifically look for lot number VCIA083 with an expiration date of JUN2020 printed on the label.

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

Return any unused product from the affected lot to the place of purchase or pharmacy for a refund.

Contact Heritage Pharmaceuticals, Inc. for further instructions regarding the return process.

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