Renaissance Lakewood Flucanazole Injection Recall: Stability Issues
Renaissance Lakewood recalls Flucanazole Injection due to stability problems that could affect drug potency and safety. This medication is prescription-only and sold in specific packaging.
Recall notice
Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
Contact the company
What happened, in plain English
Renaissance Lakewood is recalling Flucanazole Injection, 200 mg in 100 mL, because it failed stability tests. This means the medication might not be safe or effective when used as intended. Read more at govinfonow.com/recall/40796-renaissance-lakewood-flucanazole-injection-recall-stability-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/40796-renaissance-lakewood-flucanazole-injection-recall-stability-issues · Updated October 7, 2026 · FDA enforcement record: FDA #D-0605-2018
Cite this page
“Renaissance Lakewood Flucanazole Injection Recall: Stability Issues.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40796-renaissance-lakewood-flucanazole-injection-recall-stability-issues. Based on FDA recall #D-0605-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0605-2018%22&limit=1).
Why it’s dangerous
The medication failed stability tests for both drug potency and water vapor permeability. This could mean the drug becomes less effective or unsafe over time, especially if stored improperly.
Who’s affected
Prescription patients who received this specific Flucanazole Injection product. Those using it for medical treatment are most at risk due to potential instability.
How to tell if you have this one
Check for the product name 'Flucanazole Injection, USP 200 mg in 100 mL (2 mg/mL)', 10 single-dose containers, and the lot number A060644 from May 2018. It was manufactured by Renaissance Lakewood for Claris Lifesciences.
- Brand
Renaissance Lakewood- Category
Drug
What to do — step by step
Check Product Details
Look for the product name, lot number A060644, and the May 2018 manufacturing date on the container.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0605-2018 (March 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0605-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.