Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ONDANSETRON INJECTION Recalled by Fresenius Kabi USA, LLC Due to Lack of Assurance of Sterility: Glass vials may...
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 Fresenius Kabi USA, LLC directly.
Affected Products
ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-373-02
Quantity: 184,550 Vials
Why Was This Recalled?
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fresenius Kabi USA, LLC
Fresenius Kabi USA, LLC has 67 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report