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.
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.
Nationwide in the USA
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0270-2021