FDA-Drug2021-03-03Class II
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.
Areva Pharmaceuticals Inc
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.
Sold states
Nationwide in the USA
Affected count
3287 vials
Manufactured in
7112 Areva Dr Ne, N/A, Georgetown, IN, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0270-2021Don't want to check this manually?
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