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.

Recall Number: D-915-2013

Firm: Fresenius Kabi USA LLC (FK USA)

Classification: Class II

Status: Terminated

Report Date: 20130828

Initiation Date: 20130122

Termination Date: 20150512

Crystallization: Active pharmaceutical ingredient is precipitating in product solution.

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.