Agency classClass IIOur severity:Severe FDA (Drugs)·D-595-2013·Announced 2013-06-12

Pentec Health Recalls Baxter LL Bag 2% Amino Acids Due to Sterility Concerns

Pentec Health is recalling Baxter LL bag 2% Amino Acids 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe. While no specific injuries are reported in the text, the lack of sterility assurance for a sterile product is a significant hazard.

Plain-English summary

Pentec Health Inc. is recalling Baxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids) in 2500mL 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 directly to dialysis centers and patients. The specific compounding dates for the recalled bags are April 26, 2013, and April 30, 2013, with a discard-after date of May 21, 2013.

Consumers and healthcare providers should stop using the affected products and contact Pentec Health for further instructions or a replacement.

The recalled product

Product: Baxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 2500mL bag and b) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
Manufacturer: Pentec Health
Category: Drug — Compounded Sterile Preparations
Hazard: sterility-failure
Affected units: 3

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)

Compounding Date: a) 04/26/13
b) 04/30/13 Discard after: a) and b) 5/21/13

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 →

Same manufacturer · Pentec Health

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Pentec Health Recalls Baxter LL Bag Amino Acids Due to Sterility Concerns
FDA (Drugs) · 2013-06-12
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Pentec Health Recalls Baxter LL Bag Amino Acids Due to Sterility Concerns
FDA (Drugs) · 2013-06-12

Same hazard · sterility failure