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.
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 recall is classified as FDA Class II, which corresponds to a Severe severity score per the rubric, particularly given the risk of infection from non-sterile medical products.
Plain-English summary
Pentec Health Inc is recalling Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids) in 485mL and 490mL bags. The recall is due to a lack of assurance of sterility, as sterility could not be assured for the compounded sterile renal nutritional prescriptions.
The affected product was distributed to dialysis centers and directly to patients. The recall includes 25 bags with compounding dates of 04/24/13, 04/25/13, and 04/29/13, and discard dates of 05/15/13, 05/16/13, and 05/20/13.
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 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
- Manufacturer
- Pentec Health
- Affected units
- 25
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 (5)
- Compounding Date: 04/24/13
- 04/25/13
- 04/29/13 Discard after: 05/15/13
- 05/16/13
- 05/20/13
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 · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
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
- HighTPN parenteral nutrition bags recalled due to lack of sterility
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
- HighCompounded injectable medication recalled for lack of sterility assurance
FDA (Drugs) · 2022-11-09