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 Ph
Recalled March 3, 2021 · FDA recall D-0270-2021 · Areva Pharmaceuticals
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. · FDA Class II
Units
3287 vials
Sold at
Nationwide in the USA
Description
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.
Product
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.
Manufacturer(s)
Areva Pharmaceuticals Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →