Renaissance Lakewood Fluconazole Injection Recall: Superpotent Risk
Renaissance Lakewood recalls fluconazole injection (2 mg/mL) due to superpotent risk. Rx-only products with specific NDC numbers are affected. Contact for details.
Recall notice
Superpotent
Contact the company
What happened, in plain English
Renaissance Lakewood is recalling fluconazole injection products (50mL and 100mL) that are labeled as superpotent. This recall is for prescription-only medications that could pose a risk if misused. Read more at govinfonow.com/recall/41098-renaissance-lakewood-fluconazole-injection-recall-superpotent-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41098-renaissance-lakewood-fluconazole-injection-recall-superpotent-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0124-2018
Cite this page
“Renaissance Lakewood Fluconazole Injection Recall: Superpotent Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41098-renaissance-lakewood-fluconazole-injection-recall-superpotent-risk. Based on FDA recall #D-0124-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0124-2018%22&limit=1).
Why it’s dangerous
The product is labeled 'superpotent,' which means it contains a high concentration of medication that could cause serious harm if not used correctly. However, the recall record does not specify the exact mechanism of harm or how it leads to injury.
Who’s affected
Prescription patients using fluconazole injection for medical conditions. Those with the specific NDC numbers listed are most at risk.
How to tell if you have this one
Check for the product name 'Fluconazole Injection, USP, 2 mg/mL' with NDC numbers 336000-261-10 (50mL) or 33600-002-10 (100mL). These are prescription-only medications.
- Brand
Renaissance Lakewood- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC numbers 336000-261-10 or 33600-002-10 on the product label.
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 2.4 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-0124-2018 (November 11, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0124-2018 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.