Product: Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-402-05.
Reason for recall: Superpotent Drug: High out of specification assay value results for potency.
Recall initiated: 20180608
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated