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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 →- SevereK.C. Pharmaceuticals Recalls Target Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- HighFDA Recalls TPN Nutrition Bags Due to Sterility Assurance Failure
FDA (Drugs) · 2023-02-22
- HighSentara TPN Products Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-02-22
- HighPharmacy Plus Injectable Drug Recall Due to Sterility Assurance Failure
FDA (Drugs) · 2022-11-09
- HighFDA Class II: TPN solution bags lack sterility assurance
FDA (Drugs) · 2023-02-22
- HighFresenius Recalls DELFLEX Peritoneal Dialysis Solution Due to Bag Leakage
FDA (Drugs) · 2018-03-28
- HighInjectable Papaverine/Phentolamine Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2022-11-09