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Drug recall · FDA · Published July 11, 2018

Renaissance Lakewood, LLC recalls Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose

Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.

🇺🇸 FDA recall #D-1033-2018DrugRenaissance Lakewood, LLC ›
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Contact the company & request your remedy

Recalling firmRenaissance Lakewood, LLC1200 Paco Way, N/A · Lakewood, NJ 08701-5938
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
Write-up in progress

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We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.

Source Page by GovInfoNow · govinfonow.com/recall/40376-renaissance-lakewood-llc-recalls-fluconazole-injection-usp-iso-osmotic-sodium · Recall date July 11, 2018 · FDA enforcement record: FDA #D-1033-2018

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“Renaissance Lakewood, LLC recalls Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose.” GovInfoNow, recall dated July 11, 2018. https://govinfonow.com/recall/40376-renaissance-lakewood-llc-recalls-fluconazole-injection-usp-iso-osmotic-sodium. Based on FDA recall #D-1033-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1033-2018%22&limit=1).

How to tell if you have this one

  • Brand
    Renaissance Lakewood, LLC
  • Category
    Drug
FDA recall event · 3 products

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 numberProduct, codes & lotsQuantity
D-1031-2018Fluconazole 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 09/183000 bags
D-1032-2018Fluconazole 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 02/193664 bags
D-1033-2018Fluconazole 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 02/1912088 bags
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Contact Renaissance Lakewood, LLC

We’ve drafted a message you can send Renaissance Lakewood, LLC to request your refund or repair — edit it as you like.

✉️ Open in email
Subject: Recall D-1033-2018 — Renaissance Lakewood, LLC Renaissance Lakewood, LLC recalls Fluconazole Injection, USP, Iso-Osmotic

Hello,

I own a Renaissance Lakewood, LLC recalls Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose that is covered by recall D-1033-2018 from Renaissance Lakewood, LLC.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

Similar recalls

Renaissance Lakewood, LLC recalls Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only,
Renaissance Lakewood, LLC · 93% matchRenaissance Lakewood, LLC recalls Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured
Renaissance Lakewood, LLC · 91% matchRenaissance Lakewood, LLC recalls Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), package in 100 mL bags, Rx
Renaissance Lakewood, LLC · 91% matchSagent Pharmaceuticals Inc recalls Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag, Rx only, Mfd. for
Sagent Pharmaceuticals Inc · 82% matchClaris Lifesciences Inc recalls Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ,
Claris Lifesciences Inc · 82% match

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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.
  • 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA