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.
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 recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in a parenteral nutrition product, which poses a significant risk of serious injury or infection.
Plain-English summary
Pentec Health Inc. is recalling Baxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids) in 3000mL, 5000mL, and 6000mL bags. The recall was initiated because sterility could not be assured for these compounded sterile renal nutritional prescriptions.
The affected products were distributed to dialysis centers and directly to patients. The specific lots involved have compounding dates of April 25, 2013, and April 30, 2013, with discard-after dates of May 16, 2013, and May 21, 2013.
Patients and healthcare providers should stop using the affected products and contact their healthcare provider or Pentec Health for further instructions.
The recalled product
- 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
- Manufacturer
- Pentec Health
- Category
- Drug — Parenteral Nutrition
- Affected units
- 5
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 (2)
- 04/30/13 Discard After: 05/16/13
- 05/21/13
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