Medications & Supplements/Prescription Drugs

Kalchem International, Inc.: Vardenafil HCl Recalled for Lack of Stability and Expiration Date Data

Agency Publication Date: March 7, 2018

Summary

Kalchem International, Inc. is recalling one lot (about 500 grams) of Vardenafil HCl, USP (trihydrate), a prescription ingredient used for manufacturing, repackaging, and research. The recall was initiated because the company lacks the necessary stability data and controls to support the expiration or retest dates assigned to the product when stored in their container system. This means the medication's potency or safety over time cannot be guaranteed, which could lead to ineffective treatment or unexpected side effects.

Risk

Without valid stability data, the drug may degrade faster than expected or lose its effectiveness before its listed expiration date, potentially failing to provide the intended therapeutic benefit to patients.

What You Should Do

Locate your product to identify if it is part of the recall: check for Vardenafil HCl, USP (trihydrate) in a 500-gram jar with Lot Number 070717-1 and NDC 60592-330-05.
If you have this specific lot, stop using it for manufacturing, repackaging, or research immediately.
Contact your healthcare provider or pharmacist for guidance if you have concerns about medications produced using this raw ingredient.
Return any unused product to the place of purchase for a refund and contact Kalchem International, Inc. at 888-298-9905 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

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

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

Affected Products

Product: Vardenafil HCl, USP (trihydrate) (500 gram jar)

Model:

Part # 330-05

NDC 60592-330-05

Lot Numbers:

070717-1

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79304

Status: Resolved

Manufacturer: Kalchem International, Inc.

Sold By: Kalchem International, Inc.

Manufactured In: United States

Units Affected: 500 gram jar

Distributed To: Texas

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

Locate your product to identify if it is part of the recall: check for Vardenafil HCl, USP (trihydrate) in a 500-gram jar with Lot Number 070717-1 and NDC 60592-330-05.

If you have this specific lot, stop using it for manufacturing, repackaging, or research immediately.

Contact your healthcare provider or pharmacist for guidance if you have concerns about medications produced using this raw ingredient.

Return any unused product to the place of purchase for a refund and contact Kalchem International, Inc. at 888-298-9905 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.