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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Product Detail

Product Description 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
Classification Class II
Code Info Lot #: 872CZ00101, Exp 12/13
Product Distributed Qty 23,672 vials
Reason For Recall Crystallization: Active pharmaceutical ingredient is precipitating in product solution.

Event Detail

Event Id 64102
Product Type Drugs
Status Ongoing
Recalling Firm Fresenius Kabi USA LLC (FK USA)
City Schaumburg
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-22
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide