The Recall Desk

Manufacturer

Pentec Health

15 recalls in our database name Pentec Health as the manufacturing or recalling firm.

What the numbers show

Total
15
Critical
0
Severe
15
Most recent
2013-06-12

Of the 15 recalls from Pentec Health we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 15 (100%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–15 of 15

  • SevereFDA (Drugs)·D-590-2013·2013-06-12

    Pentec Health Recalls Proplete 80+ KG Due to Sterility Concerns

    Pentec Health is recalling Proplete 80+ KG renal nutritional prescriptions because sterility could not be assured for the compounded sterile products.

    Product
    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
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-595-2013·2013-06-12

    Pentec Health Recalls Baxter LL Bag 2% Amino Acids Due to Sterility Concerns

    Pentec Health is recalling Baxter LL bag 2% Amino Acids because sterility could not be assured for the compounded sterile renal nutritional prescriptions.

    Product
    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
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-593-2013·2013-06-12

    Pentec Health Recalls Baxter LL Bag 1% Amino Acids Due to Sterility Concerns

    Pentec Health is recalling Baxter LL bag 1% Amino Acids w/KCL because sterility could not be assured for these compounded sterile renal nutritional prescriptions.

    Product
    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
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-586-2013·2013-06-12

    Pentec Health Recalls Proplete 40 Intradialytic Parenteral Nutrition Bags

    Pentec Health is recalling 9 bags of Proplete 40 intradialytic parenteral nutrition due to a lack of assurance of sterility.

    Product
    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
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-594-2013·2013-06-12

    Pentec Health Recalls Baxter LL Bag Amino Acids Due to Sterility Concerns

    Pentec Health is recalling Baxter LL bag 1.5% Amino Acids because sterility could not be assured for the compounded sterile renal nutritional prescriptions.

    Product
    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
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-583-2013·2013-06-12

    Pentec Health Recalls Baxter LL Bag Amino Acids Due to Sterility Concerns

    Pentec Health is recalling Baxter LL bag 1% Amino Acids because sterility could not be assured for the compounded sterile renal nutritional prescriptions.

    Product
    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
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-582-2013·2013-06-12

    Pentec Health Recalls Baxter Ultrabag Amino Acids Due to Sterility Concerns

    Pentec Health is recalling Baxter Ultrabag 1.5% Amino Acids because sterility could not be assured for compounded sterile renal nutritional prescriptions.

    Product
    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
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-587-2013·2013-06-12

    Pentec Health Recalls Proplete 52 Intradialytic Nutrition Due to Sterility Concerns

    Pentec Health is recalling Proplete 52 intradialytic parenteral nutrition bags because sterility could not be assured for the compounded sterile renal nutritional prescriptions.

    Product
    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
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-584-2013·2013-06-12

    Pentec Health Recalls Fresenius Amino Acid Bags Due to Sterility Concerns

    Pentec Health is recalling Fresenius 1% Amino Acid bags because sterility could not be assured for compounded renal nutritional prescriptions.

    Product
    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
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-592-2013·2013-06-12

    Pentec Health Recalls Proplete 45-51 KG Due to Sterility Concerns

    Pentec Health is recalling Proplete 45-51 KG intraperitoneal nutrition bags because sterility could not be assured for the compounded sterile renal nutritional prescriptions.

    Product
    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
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-589-2013·2013-06-12

    Pentec Health Recalls Proplete 70+ KG Due to Sterility Concerns

    Pentec Health is recalling 38 bags of Proplete 70+ KG renal nutritional solution because sterility could not be assured for the compounded product.

    Product
    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
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-581-2013·2013-06-12

    Pentec Health Recalls Proplete 34-39 KG Intradialytic Nutrition Bags

    Pentec Health is recalling Proplete 34-39 KG intradialytic parenteral nutrition bags because sterility could not be assured for the compounded sterile renal nutritional prescriptions.

    Product
    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
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-585-2013·2013-06-12

    Pentec Health Recalls Intradialytic Parenteral Nutrition Bags Due to Sterility Concerns

    Pentec Health is recalling specific lots of IDPN dialysate solution bags because sterility could not be assured. The products were distributed to dialysis centers and directly to patients.

    Product
    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
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-588-2013·2013-06-12

    Pentec Health Recalls Proplete 60-69 KG Intradialytic Nutrition Bags

    Pentec Health is recalling 59 bags of Proplete 60-69 KG intradialytic parenteral nutrition due to a lack of assurance of sterility.

    Product
    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
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-591-2013·2013-06-12

    Pentec Health Recalls Proplete 90+ KG Due to Sterility Concerns

    Pentec Health is recalling Proplete 90+ KG dialysate solution because sterility could not be assured. The product was distributed to dialysis centers and directly to patients.

    Product
    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
    Category
    Drug
    Distribution
    0 states