Medications & Supplements/Prescription Drugs

Renaissance Lakewood, LLC: Flucanazole Injection Recalled for Superpotency and Stability Failure

Agency Publication Date: March 23, 2018

Summary

Approximately 1,277 bags of Flucanazole (fluconazole) Injection, USP 200 mg in 100 mL (2 mg/mL) are being recalled. This prescription medication, distributed in packs of 10 single-dose flexible containers, was found to be superpotent, meaning it contains more active medication than intended. The recall was also initiated because the product failed stability tests for water vapor permeability, which can affect the drug's quality over time.

Risk

Receiving a superpotent medication can result in a patient getting a higher dose than prescribed, which may lead to an increased risk of adverse side effects or toxicity. Additionally, failure to meet stability standards for water vapor permeability means the product may not maintain its concentration or effectiveness through its shelf life.

What You Should Do

Check your medical supplies or prescription records for Flucanazole (fluconazole) Injection, USP 200 mg in 100 mL (2 mg/mL) in flexible containers.
Identify affected products by looking for NDC 36000-006-10 and Lot number A060644 with an expiration date of May 2018.
If you have the affected product, contact your healthcare provider or pharmacist immediately for guidance on alternatives and safety.
Return any unused bags from Lot A060644 to the place of purchase for a refund and contact the manufacturer, Renaissance Lakewood, LLC, for further handling instructions.
For additional questions or to report a concern, 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 consultation and product return

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

Affected Products

Product: Flucanazole Injection, USP 200 mg in 100 mL (2 mg/mL)

Model:

NDC 36000-006-10

Lot Numbers:

A060644 (Exp May 2018)

Date Ranges: Expiration May 2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79310

Status: Resolved

Manufacturer: Renaissance Lakewood, LLC

Manufactured In: India, United States

Units Affected: 1277 bags

Distributed To: Nationwide

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

Risk

What You Should Do

Check your medical supplies or prescription records for Flucanazole (fluconazole) Injection, USP 200 mg in 100 mL (2 mg/mL) in flexible containers.

Identify affected products by looking for NDC 36000-006-10 and Lot number A060644 with an expiration date of May 2018.

If you have the affected product, contact your healthcare provider or pharmacist immediately for guidance on alternatives and safety.

Return any unused bags from Lot A060644 to the place of purchase for a refund and contact the manufacturer, Renaissance Lakewood, LLC, for further handling instructions.

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