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U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

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Product Detail

Product Description 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
Recall Number D-688-2013
Classification Class III
Code Info Lot #: 6103883, Exp 10/2013
Product Distributed Qty 80,480 vials
Reason For Recall Failed Impurities/Degradation Specification

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 Letter
Distribution Pattern Nationwide and Puerto Rico