Renaissance Lakewood Fluconazole Injection Recall: Label Mix-Up Risk
Renaissance Lakewood recalls Fluconazole Injection 200mg/100mL due to a label mix-up where 50mL bags were found in 100mL packages. This may cause incorrect dosing in medical use.
Lower-risk recall
Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride Diluent, USP, 2mg/mL, 50 mL found within the package of 100 mL bags.
Contact the company
What happened, in plain English
Renaissance Lakewood is recalling Fluconazole Injection 200mg in 100mL bags because a complaint found 50mL bags inside the 100mL packages. This could lead to incorrect dosing if used without proper identification. Read more at govinfonow.com/recall/40803-renaissance-lakewood-fluconazole-injection-recall-label-mix-up-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40803-renaissance-lakewood-fluconazole-injection-recall-label-mix-up-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0696-2018
Cite this page
“Renaissance Lakewood Fluconazole Injection Recall: Label Mix-Up Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40803-renaissance-lakewood-fluconazole-injection-recall-label-mix-up-risk. Based on FDA recall #D-0696-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0696-2018%22&limit=1).
Why it’s dangerous
The label mix-up means 50mL bags were mistakenly included in 100mL packages. This could cause incorrect dosing if healthcare providers use the wrong package size for their treatment.
Who’s affected
Healthcare professionals using this medication for medical treatments. Patients receiving injections under medical supervision are most at risk due to potential dosing errors.
How to tell if you have this one
Check for 100mL bags labeled 'Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL)'. The product was manufactured with lot number A0A0539 and expires May 2019.
- Brand
Renaissance Lakewood- Category
Drug
What to do — step by step
Check Package Label
Look for the presence of a 50mL bag inside the 100mL package.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Product was distributed throughout the United States.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 18 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- 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-0696-2018 (February 21, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0696-2018 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.