Ingenus Pharmaceuticals Llc recalls Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: I
Recalled July 11, 2018 · FDA recall D-0890-2018 · Ingenus Pharmaceuticals
Hazard
Superpotent Drug: High out of specification assay value results for potency. · FDA Class II
Units
34964 vials
Sold at
Nationwide in the USA
Description
Superpotent Drug: High out of specification assay value results for potency.
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.
Manufacturer(s)
Ingenus Pharmaceuticals Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →