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U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

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Event Detail

Event ID 65213
Product Type Drugs
Status Ongoing
Recalling Firm Fresenius Kabi USA, LLC
City Lake Zurich
State IL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-21
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide and Puerto Rico

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dose Vial, Rx only, APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-184-11 Lot #: 6103883, Exp 10/2013 Class III Failed Impurities/Degradation Specification 80,480 vials D-688-2013