FDA recall D-915-2013

Fresenius Kabi USA LLC (FK USA) · Class II · drug

Product

IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-193-02, UPC 3 63323 19302 7.

Reason for recall

Crystallization: Active pharmaceutical ingredient is precipitating in product solution.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-01-22
Report date: 2013-08-28
Termination date: 2015-05-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Schaumburg, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-915-2013