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.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a parenteral product, which poses a significant risk of serious injury or infection.
Plain-English summary
Pentec Health is recalling 38 bags of Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids). The product is available in 635mL and 660mL bags. The recall was initiated because sterility could not be assured for these compounded sterile renal nutritional prescriptions.
The affected product was compounded on April 24, 2013, and had a discard-after date of May 15, 2013. The product was distributed directly to patients and to dialysis centers.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or Pentec Health for further instructions.
The recalled 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
- Manufacturer
- Pentec Health
- Category
- Drug — Renal Nutrition
- Affected units
- 38
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Compounding Date: 04/24/13 Discard after: 05/15/13
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 15 recalled by Pentec Health under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 15 products in this recall →Related recalls
Same manufacturer · Pentec Health
See all →- SeverePentec Health Recalls Proplete 80+ KG Due to Sterility Concerns
FDA (Drugs) · 2013-06-12
- SeverePentec Health Recalls Baxter LL Bag 2% Amino Acids Due to Sterility Concerns
FDA (Drugs) · 2013-06-12
- SeverePentec Health Recalls Baxter LL Bag 1% Amino Acids Due to Sterility Concerns
FDA (Drugs) · 2013-06-12
- SeverePentec Health Recalls Proplete 40 Intradialytic Parenteral Nutrition Bags
FDA (Drugs) · 2013-06-12
- SeverePentec Health Recalls Baxter LL Bag Amino Acids Due to Sterility Concerns
FDA (Drugs) · 2013-06-12
Same hazard · sterility
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29