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Unrated Drug recall · FDA · Published November 6, 2017

Claris Ciprofloxacin Dextrose Injection Recall: Superpotent Risk

Claris recalls Ciprofloxacin in 5% Dextrose injection due to superpotent risk. This medication is for prescription use only and may cause serious harm if misused.

🇺🇸 FDA recall #D-0127-2018DrugClaris ›
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Recalling firmClaris Lifesciences Inc1445 US Highway 130 · North Brunswick, NJ 08902-3100
✎ GovInfoNow plain-language explainer

What happened, in plain English

Claris has recalled a specific prescription injection of Ciprofloxacin in 5% Dextrose. The recall is due to a superpotent risk, which could lead to serious harm if the medication is used incorrectly. Read more at govinfonow.com/recall/41106-claris-ciprofloxacin-dextrose-injection-recall-superpotent-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/41106-claris-ciprofloxacin-dextrose-injection-recall-superpotent-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0127-2018

Cite this page

“Claris Ciprofloxacin Dextrose Injection Recall: Superpotent Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41106-claris-ciprofloxacin-dextrose-injection-recall-superpotent-risk. Based on FDA recall #D-0127-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0127-2018%22&limit=1).

Why it’s dangerous

The term 'superpotent' indicates the medication may be significantly more potent than intended, potentially causing severe side effects or harm if not properly administered. This risk is particularly concerning for prescription use only products.

Who’s affected

Prescription patients who received this specific Ciprofloxacin injection from Claris. Those with medical conditions requiring this medication are most at risk.

How to tell if you have this one

Check for the product name: Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only. Look for the NDC code 36000-008-249 or the specific manufacturing dates listed in the recall.

  • Brand
    Claris
  • Product
    Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (2 mg/mL), 100 mL Flexible Bag
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the product name and NDC code to confirm if your medication is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

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 2.5 years after the firm started it.

1. Firm started the recall: Nov 6, 201712. FDA classified it Class III: Dec 21, 201723. Published in FDA’s Enforcement Report: Dec 27, 201734. FDA terminated the recall: Apr 20, 2020420172020
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is this medication safe to use?

The recall states it has a 'superpotent' risk, meaning it may cause serious harm if misused. It is not safe to use without proper medical supervision.

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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-0127-2018 (November 6, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0127-2018 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.
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