Renaissance Lakewood Fluconazole Injection Recall: Superpotent Drug Risk
Renaissance Lakewood recalls fluconazole injection due to elevated sodium chloride and fluconazole levels. This may cause serious health risks. Contact for return instructions.
Recall notice
Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
Contact the company
What happened, in plain English
Renaissance Lakewood is recalling fluconazole injections that have elevated sodium chloride and fluconazole levels. These issues could lead to serious health risks if used improperly. Read more at govinfonow.com/recall/40376-renaissance-lakewood-fluconazole-injection-recall-superpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40376-renaissance-lakewood-fluconazole-injection-recall-superpotent-drug-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-1033-2018
Cite this page
“Renaissance Lakewood Fluconazole Injection Recall: Superpotent Drug Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/40376-renaissance-lakewood-fluconazole-injection-recall-superpotent-drug-risk. Based on FDA recall #D-1033-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1033-2018%22&limit=1).
Why it’s dangerous
The injection has higher-than-stated sodium chloride and fluconazole concentrations. This could cause serious health issues like adverse reactions or incorrect dosing if used.
Who’s affected
Healthcare professionals who use this medication for treating fungal infections. Patients receiving this injection under medical supervision are at risk.
How to tell if you have this one
Look for the product name 'Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose'. Check the NDC numbers 36000-002-10 and 36000-002-06. The lot numbers and expiration dates are listed in the recall notice.
- Brand
Renaissance Lakewood- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide and Puerto Rico
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1031-2018 | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India; NDC 36000-003-06.; Lot # A061213, Exp 09/18 | 3000 bags |
| D-1032-2018 | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-002-10.; Lot #: A0A0156, Exp 02/19 | 3664 bags |
| D-1033-2018 | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC a) 36000-002-10 and b) 36000-002-06.; Lot #: a) A060966, A060967, A060965, A061023, Exp 07/18; b) A060962, Exp 02/19 | 12088 bags |
What to do — step by step
Check Product Details
Verify the NDC numbers 36000-002-10 and 36000-002-06 on the product label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.7 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-1033-2018 (July 11, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1033-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.