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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Renaissance Lakewood, LLC: Fluconazole Injection Recalled for Being Superpotent

Agency Publication Date: December 20, 2017
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Summary

Renaissance Lakewood, LLC is recalling 24,569 bags of Fluconazole Injection, USP (2 mg/mL) because the medication is superpotent, meaning it contains a higher concentration of the drug than intended. This recall affects the 50 mL and 100 mL bags manufactured for Claris LifeSciences. Using a superpotent medication can result in an overdose, which may cause serious health complications depending on the patient's condition. If you have this medication, you should immediately contact your healthcare provider or pharmacist for guidance and instructions on returning the product.

Risk

The medication is superpotent and contains an excessively high concentration of the active ingredient, which can lead to accidental overdose and potential toxicity in patients.

What You Should Do

  1. Check your Fluconazole Injection, USP (2 mg/mL) packaging for the following details: 50 mL bags with NDC 336000-261-10 or 100 mL bags with NDC 33600-002-10.
  2. Identify if your 50 mL bags match any of these lot numbers and expiration dates: A060174 (Exp 01/13/2018), A060257 (Exp 02/28/2018), A060692 (Exp 05/31/2018), A061165 (Exp 09/30/2018), A0A0143 (Exp 01/31/2019), A0A0347 (Exp 03/31/2019), or A0A0424 (Exp 04/30/2019).
  3. Identify if your 100 mL bags match lot number A060027 with an expiration date of 12/31/2017.
  4. If your medication is part of this recall, contact your healthcare provider or pharmacist immediately for medical guidance and to arrange for a replacement.
  5. Return any unused or affected product to the pharmacy where it was purchased to receive a refund and ensure the superpotent drug is properly handled.
  6. Contact the manufacturer, Renaissance Lakewood, LLC, for further instructions regarding the return process.
  7. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull 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: Fluconazole Injection, USP, 2 mg/mL (50 mL)
Model:
NDC 336000-261-10
Lot Numbers:
A060174 (Exp 01/13/2018)
A060257 (Exp 02/28/2018)
A060692 (Exp 05/31/2018)
A061165 (Exp 09/30/2018)
A0A0143 (Exp 01/31/2019)
A0A0347 (Exp 03/31/2019)
A0A0424 (Exp 04/30/2019)
Product: Fluconazole Injection, USP, 2 mg/mL (100 mL)
Model:
NDC 33600-002-10
Lot Numbers:
A060027 (Exp 12/31/2017)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78504
Status: Resolved
Manufacturer: Renaissance Lakewood, LLC
Sold By: Claris LifeSciences, Inc.
Manufactured In: United States, India
Units Affected: 24,569 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 ยท 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.