FDA-Drug2018-07-11Class II
Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-401-02.
Ingenus Pharmaceuticals Llc
Hazard
Superpotent Drug: High out of specification assay value results for potency.
Sold states
Nationwide in the USA
Affected count
14089 vials
Manufactured in
4190 Millenia Blvd, Orlando, FL, United States
Products
Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-401-02.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0891-2018Don't want to check this manually?
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