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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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Product Detail

Product Description 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.
Recall Number D-804-2013
Classification Class II
Code Info Lot #: 6003648, Exp. 6/2013
Product Distributed Qty 221,600 vials
Reason For Recall Subpotent Drug; 15-month stability test station

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