FDA recall D-0891-2018

Product

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.

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-06-08

Report date

2018-07-11

Termination date

2019-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Orlando, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0891-2018