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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Product Detail

Product Description Proplete 60 - 69 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in 555mL bag, Pentec Health Inc, 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
Recall Number D-588-2013
Classification Class II
Code Info Compounding Date: 04/23/13, 04/24/13, 04/29/13, 05/01/13 Discard after: 05/20/13, 05/22/13
Product Distributed Qty 59 Bags
Reason For Recall Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

Event Detail

Event Id 65180
Product Type Drugs
Status Ongoing
Recalling Firm Pentec Health
City Boothwyn
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-15
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Dialysis Centers Direct to patient