Medications & Supplements/Prescription Drugs

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

Agency Publication Date: August 2, 2018

Summary

Renaissance Lakewood, LLC is recalling 18,752 bags of Fluconazole Injection, USP (2 mg/mL) in 100 mL and 200 mL sizes. These prescription antifungal medications are being recalled because testing showed they were "superpotent," meaning they contained higher-than-expected levels of fluconazole and sodium chloride, or failed stability testing for water vapor. Consumers using these products may receive an incorrect dosage or a product that has not maintained its required chemical balance over time. You should contact your healthcare provider or pharmacist immediately if you have any of the affected lots.

Risk

The affected IV bags contain elevated levels of sodium chloride and active fluconazole, which can lead to patients receiving a higher dose of medication than prescribed. Additionally, failed stability for water vapor indicates the product's concentration may change over time, potentially impacting the safety and effectiveness of the treatment.

What You Should Do

Check your Fluconazole Injection bags for the following National Drug Codes (NDC): 36000-003-06, 36000-002-10, or 36000-002-06.
Identify if your product is affected by checking for Lot A061213 (Exp 09/18) on the 200 mL bags (400 mg dose).
Identify if your product is affected by checking for Lots A0A0156 (Exp 02/19), A060966 (Exp 07/18), A060967 (Exp 07/18), A060965 (Exp 07/18), A061023 (Exp 07/18), or A060962 (Exp 02/19) on the 100 mL bags (200 mg dose).
Contact your healthcare provider or pharmacist immediately for guidance if you have any of these affected lots in your possession.
Return any unused product to the pharmacy or place of purchase for a refund and contact Renaissance Lakewood, LLC for further instructions.
For additional questions or to report a complaint, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund

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, 400 mg in 200 mL (2 mg/mL)

Model:

NDC 36000-003-06

Lot Numbers:

A061213 (Exp 09/18)

Date Ranges: September 2018

Product: Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL)

Model:

NDC 36000-002-10

Lot Numbers:

A0A0156 (Exp 02/19)

Date Ranges: February 2019

Product: Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL)

Model:

NDC 36000-002-10

NDC 36000-002-06

Lot Numbers:

A060966 (Exp 07/18)

A060967 (Exp 07/18)

A060965 (Exp 07/18)

A061023 (Exp 07/18)

A060962 (Exp 02/19)

Date Ranges: July 2018, February 2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80442

Status: Resolved

Manufacturer: Renaissance Lakewood, LLC

Sold By: Hospitals; Pharmacies

Manufactured In: India, United States

Units Affected: 3 products (3000 bags; 3664 bags; 12088 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 Fluconazole Injection bags for the following National Drug Codes (NDC): 36000-003-06, 36000-002-10, or 36000-002-06.

Identify if your product is affected by checking for Lot A061213 (Exp 09/18) on the 200 mL bags (400 mg dose).

Identify if your product is affected by checking for Lots A0A0156 (Exp 02/19), A060966 (Exp 07/18), A060967 (Exp 07/18), A060965 (Exp 07/18), A061023 (Exp 07/18), or A060962 (Exp 02/19) on the 100 mL bags (200 mg dose).

Contact your healthcare provider or pharmacist immediately for guidance if you have any of these affected lots in your possession.

Return any unused product to the pharmacy or place of purchase for a refund and contact Renaissance Lakewood, LLC for further instructions.

For additional questions or to report a complaint, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL)

Model:

NDC 36000-003-06

Lot Numbers:

A061213 (Exp 09/18)

Date Ranges: September 2018

Product: Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL)

Model:

NDC 36000-002-10

Lot Numbers:

A0A0156 (Exp 02/19)

Date Ranges: February 2019

Product: Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL)

Model:

NDC 36000-002-10

NDC 36000-002-06

Lot Numbers:

A060966 (Exp 07/18)

A060967 (Exp 07/18)

A060965 (Exp 07/18)

A061023 (Exp 07/18)

A060962 (Exp 02/19)

Date Ranges: July 2018, February 2019