Irinotecan Hydrochloride Injection recalled over manufacturing violations

Recall date

November 19, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Areva Pharmaceuticals Inc recalls Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 2 mL Single-Dose Vial, Rx Only, Distributed by: Areva P…

Recall number

D-0270-2021

FDA classification

Class II

Brand / firm

Areva Pharmaceuticals Inc

Sold / distributed

Nationwide in the USA

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.