Key Takeaway
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 19061-313 by Pentec Health was recalled on May 15, 2013. The hazard: Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions
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 19061-313
Description
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
Hazard / Reason
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions
Class II: Product that may cause temporary or medically reversible health consequences.
Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.
Products Affected
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 19061-313
DrugsCompany Information
Pentec Health
Boothwyn, PA, United States
View all 15 recalls by Pentec Health →Distribution
Dialysis Centers Direct to patient
Related Recalls
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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
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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
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Frequently Asked Questions
Is this recall still active?
Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.
How do I check if my product is affected?
Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.
What remedy is available for this recall?
Check the remedy section above or contact the manufacturer directly for current remedy options.
Where can I find the original recall notice?
This recall was issued by FDA Drug. Visit the agency's official website for the original notice.