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FDANovember 19, 2020drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

areva pharmaceuticalsareva

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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. — Recall Details · AllClear