Drug recall D-915-2013

Class II Terminated reported Aug 28, 2013

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.

Lots and codes

Lot #: 872CZ00101, Exp 12/13

Recall details

Recalling firm
Fresenius Kabi USA LLC (FK USA), Schaumburg, IL
Quantity
23,672 vials
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
January 22, 2013
Terminated
May 12, 2015

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