Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Irinotecan Hydrochloride Injection Recalled by Areva Pharmaceuticals Inc Due to CGMP Deviations: based on a Warning Letter received...
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 Areva Pharmaceuticals Inc directly.
Affected Products
Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 2 mL Single-Dose Vial, Rx Only, Distributed by: Areva Pharmaceuticals, Inc., Gerogetown, IN 47122, Made in India, NDC 59923-714-02.
Quantity: 3287 vials
Why Was This Recalled?
CGMP Deviations: based on a Warning Letter received by the manufacturer of the recalled product for inadequate out-of specification investigations, complaint and the investigation conclusions.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Areva Pharmaceuticals Inc
Areva Pharmaceuticals Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report