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Drug recall · FDA · Published March 10, 2017

Claris Lifesciences Inc recalls Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ,

Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.

🇺🇸 FDA recall #D-0614-2017DrugClaris Lifesciences Inc ›
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Contact the company & request your remedy

Recalling firmClaris Lifesciences Inc1445 US Highway 130 · North Brunswick, NJ 08902-3100
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

We’re still writing up this recall

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/41817-claris-lifesciences-inc-recalls-fluconazole-injection-usp-400-mg-in · Recall date March 10, 2017 · FDA enforcement record: FDA #D-0614-2017

Cite this page

“Claris Lifesciences Inc recalls Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ,.” GovInfoNow, recall dated March 10, 2017. https://govinfonow.com/recall/41817-claris-lifesciences-inc-recalls-fluconazole-injection-usp-400-mg-in. Based on FDA recall #D-0614-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0614-2017%22&limit=1).

How to tell if you have this one

  • Brand
    Claris Lifesciences Inc
  • Category
    Drug
FDA recall event · 4 products

All 4 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 II
  • Status
    Terminated
  • Distribution
    Nationwide
Recall numberProduct, codes & lotsQuantityNDC
D-0613-2017Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-009-24; Lot #: A051288, Exp. Sep 201718,360 units (765 cartons x 24 bags)—
D-0614-2017Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-003-06; Lot #: A051052, Exp. Aug 201718,096 units (3016 cartons x 6 bags)—
D-0615-2017Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-048-24; Lot #: A060040, Exp. Dec 201724,456 units (1019 cartons x 24 bags)36000-045-01, 36000-046-24, 36000-047-24, 36000-048-24
D-0616-2017Metronidazole Injection, USP, 500 mg/100 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-001-24; Lot #: A060205; A060209, Exp.Jan 201872072 units—
Take action

Contact Claris Lifesciences Inc

We’ve drafted a message you can send Claris Lifesciences Inc to request your refund or repair — edit it as you like.

✉️ Open in email
Subject: Recall D-0614-2017 — Claris Lifesciences Inc Claris Lifesciences Inc recalls Fluconazole Injection, USP, 400 mg in 200 m

Hello,

I own a Claris Lifesciences Inc recalls Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, that is covered by recall D-0614-2017 from Claris Lifesciences Inc.

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

Baxter Healthcare Corp. recalls Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL
Baxter Healthcare Corp. · 85% matchBaxter Healthcare Corporation recalls Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter
Baxter Healthcare Corporation · 85% matchClaris Lifesciences Inc recalls Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (2 mg/mL), 100 mL Flexible Bag,
Claris Lifesciences Inc · 83% 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 · 83% matchRenaissance 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 · 83% 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-0614-2017 (March 10, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0614-2017 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