Medications & Supplements/Prescription Drugs

Renaissance Lakewood, LLC: Fluconazole Injection Recalled Due to Label Mix-Up and Incorrect Bag Size

Agency Publication Date: April 19, 2018

Summary

Approximately 1,784 bags of Fluconazole Injection, USP (200 mg in 100 mL) are being recalled because some packages may contain the wrong size product. Specifically, a 50 mL bag of the medication was found inside a package labeled for 100 mL bags, which could lead to incorrect dosing. Consumers should immediately check their supply for the affected lot and contact their healthcare provider or pharmacist.

Risk

A labeling mix-up where a smaller volume bag is placed in a larger volume package can result in a patient receiving half the intended dose of medication. This under-dosing may fail to treat the underlying fungal infection effectively, potentially leading to a worsening of the patient's medical condition.

What You Should Do

Check your medication for Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL).
Look for Lot Number A0A0539 with an expiration date of 05/19 (May 2019) on the product packaging.
Identify the National Drug Code (NDC) 36000-002-10 on the label to verify if your product is included in this recall.
If you identify an affected product, contact your healthcare provider or pharmacist immediately for guidance and to ensure you receive the correct dosage.
Return any unused product to the pharmacy where it was purchased for a refund.
Contact the manufacturer, Renaissance Lakewood, LLC, for further instructions regarding this recall.
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

Product return and healthcare consultation

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

Affected Products

Product: Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent (200 mg in 100 mL)

Model:

NDC 36000-002-10

Lot Numbers:

A0A0539 (Exp. 05/19)

Date Ranges: May 2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79580

Status: Resolved

Manufacturer: Renaissance Lakewood, LLC

Manufactured In: United States, India

Units Affected: 1784 bags

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

Risk

What You Should Do

Check your medication for Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL).

Look for Lot Number A0A0539 with an expiration date of 05/19 (May 2019) on the product packaging.

Identify the National Drug Code (NDC) 36000-002-10 on the label to verify if your product is included in this recall.

If you identify an affected product, contact your healthcare provider or pharmacist immediately for guidance and to ensure you receive the correct dosage.

Return any unused product to the pharmacy where it was purchased for a refund.

Contact the manufacturer, Renaissance Lakewood, LLC, for further instructions regarding this recall.

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.