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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 385mL and b) 390mL, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132 Compounding Date: 04/24/13 Discard after: 05/15/13 Class II Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. 9 Bags D-586-2013
IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), a) 490mL bag, b) 500mL bag, and c) 590mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132 Compounding Date: a) 04/25/13, b) 04/24/13 Discard After: a) 05/20/13, b) and c) 05/15/13 Class II Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. 3 Bags D-585-2013
Fresenius bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), 1000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132 Compounding Date: 04/30/13 Discard after: 05/21/13 Class II Sterility could not be assured for compounded sterile renal nutritional prescriptions. 1 Bag D-584-2013
Baxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 3000mL bag, b) 5000mL bag and c) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132 a) Compounding Date: 04/30/13 Discard After: 05/21/13 b) Compounding Date: 04/30/13 Discard After: 05/21/13 c) Compounding Date: 04/25/13, 04/30/13 Discard After: 05/16/13, 05/21/13 Class II Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. 5 Bags D-583-2013
Baxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1500mL and b) 3000mL bags. Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132 Date: 04/30/13 Discard After: 05/21/13 Class II Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. 3 units D-582-2013
Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and sterile water), in 330mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-13132 Compounding Date: 4/25/13 Discard after: 5/16/13 Class II Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. 1 Bag D-581-2013
Baxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 2500mL bag and b) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132 Compounding Date: a) 04/26/13, b) 04/30/13 Discard after: a) and b) 5/21/13 Class II Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. 3 Bags D-595-2013
Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1000mL bag, b) 2000mL bag, c) 2500mL bag, d) 5000mL bag, and e) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132 Compounding Date: 04/24/13, 04/29/13 Discard after: 5/21/13, 05/22/13 Class II Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. 8 Bags D-594-2013
Baxter LL bag 1% Amino Acids w/KCL (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids and KCL), in 3000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132 Compounding Date: 04/29/13 Discard after: 5/21/13 Class II Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. 1 Bag D-593-2013
Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 435mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132 Compounding Date: 04/24/13 Discard after: 5/15/13 Class II Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. 4 Bags D-592-2013
Proplete 90+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 805mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132 Compounding Date: 04/23/13 Discard after: 5/15/13 Class II Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. 1 Bag D-591-2013
Proplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 710mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132 Compounding Date: 04/24/13 Discard after: 5/15/13 Class II Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. 1 Bag D-590-2013
Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 635mL bag and b) 660mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132 Compounding Date: 04/24/13 Discard after: 05/15/13 Class II Sterility could not be assured for compounded sterile renal nutritional prescriptions. 38 Bags D-589-2013
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 Compounding Date: 04/23/13, 04/24/13, 04/29/13, 05/01/13 Discard after: 05/20/13, 05/22/13 Class II Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. 59 Bags D-588-2013
Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 485mL bag and b) 490mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132 Compounding Date: 04/24/13, 04/25/13, 04/29/13 Discard after: 05/15/13, 05/16/13, 05/20/13 Class II Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. 25 Bags D-587-2013
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