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:…

Recall date

June 8, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0890-2018

FDA classification

Class II

Brand / firm

Ingenus Pharmaceuticals Llc

Sold / distributed

Nationwide in the USA

Why it was recalled

Superpotent Drug: High out of specification assay value results for potency.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.