Claris Fluconazole Injection Recall: Risk of Sterility Breach in 400mg/200mL
Claris Lifesciences recalls Fluconazole Injection 400mg/200mL due to potential sterility breach from container leaks. This medication is prescription-only and may cause contamination if not properly handled.
Lower-risk recall
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.
Contact the company
What happened, in plain English
Claris Lifesciences has recalled Fluconazole Injection (400 mg in 200 mL) because there's a risk of the container leaking, which could lead to contamination. This is a prescription medication that patients must use carefully to avoid infection risks. Read more at govinfonow.com/recall/41817-claris-fluconazole-injection-recall-risk-of-sterility-breach-in-400mg.
Source Summary by GovInfoNow · govinfonow.com/recall/41817-claris-fluconazole-injection-recall-risk-of-sterility-breach-in-400mg · Updated October 8, 2026 · FDA enforcement record: FDA #D-0614-2017
Cite this page
“Claris Fluconazole Injection Recall: Risk of Sterility Breach in 400mg/200mL.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41817-claris-fluconazole-injection-recall-risk-of-sterility-breach-in-400mg. Based on FDA recall #D-0614-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0614-2017%22&limit=1).
Why it’s dangerous
The injection vial may leak, creating a risk of contamination. This could happen during storage or use, potentially leading to infections if the medication is not sterile.
Who’s affected
Prescription patients using Fluconazole Injection 400 mg in 200 mL. Those with the specific lot number A051052 are most at risk due to potential container leaks.
How to tell if you have this one
Check for the product name 'Fluconazole Injection, USP, 400 mg in 200 mL'. Look for the lot number A051052 on the label. This medication was manufactured for Claris Lifesciences Inc in North Brunswick, NJ.
- Brand
Claris Lifesciences- Category
Drug
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 number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0613-2017 | Ciprofloxacin 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 2017 | 18,360 units (765 cartons x 24 bags) | — |
| D-0614-2017 | Fluconazole 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 2017 | 18,096 units (3016 cartons x 6 bags) | — |
| D-0615-2017 | Levofloxacin 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 2017 | 24,456 units (1019 cartons x 24 bags) | 36000-045-01, 36000-046-24, 36000-047-24, 36000-048-24 |
| D-0616-2017 | Metronidazole 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 2018 | 72072 units | — |
What to do — step by step
Check Product Label
Look for the lot number A051052 on the label to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
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 3.5 years 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.
Questions people ask
Is this product safe to use?
The recall indicates a potential risk of contamination from leaks, so it's not safe to use without checking the lot number.
What should I do if I have this product?
Check the product label for lot number A051052. If it matches, stop using it and contact your healthcare provider.
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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.
- Plain-language summary written by qwen3:4b on October 8, 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.