Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fluconazole Injection Recalled by Claris Lifesciences Inc Due to Lack of Assurance of Sterility: there is potential...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Claris Lifesciences Inc directly.
Affected Products
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
Quantity: 18,096 units (3016 cartons x 6 bags)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Claris Lifesciences Inc
Claris Lifesciences Inc has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report