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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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Event Detail

Event ID 65512
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 2013-06-24
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide and Puerto Rico

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01. Lot #: 6003648, Exp. 6/2013 Class II Subpotent Drug; 15-month stability test station 221,600 vials D-804-2013
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