Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 2 mL Single-Dose Vial, Rx Only, D...
FDA Recall #D-0270-2021 — Class II — November 19, 2020
Product Description
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.
Reason for Recall
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.
Recalling Firm
Areva Pharmaceuticals Inc — Georgetown, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
3287 vials
Distribution
Nationwide in the USA
Code Information
Lot 7S10022A, Exp Jan-21
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated