Areva Pharmaceuticals recalls

FDA enforcement reports naming Areva Pharmaceuticals Inc as the recalling firm.

Recall reports: 1
Class I (serious): 0
Most recent report: Mar 3, 2021

Severity

Mar 3, 2021Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 2 mL Single-Dose Vial,…Drug · Areva Pharmaceuticals IncCGMP 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