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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot #: 872CZ00101, Exp 12/13 Class II Crystallization: Active pharmaceutical ingredient is precipitating in product solution. 23,672 vials D-915-2013
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