FDAClass IIJune 12, 2013

Baxter LL bag 1% Amino Acids recall: Sterility Concern

Baxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 3000mL bag, b) 5000mL bag and…

Why was Baxter LL bag 1% Amino Acids recalled?

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

a) Compounding Date: 04/30/13 Discard After: 05/21/13 b) Compounding Date: 04/30/13 Discard After: 05/21/13 c) Compounding Date: 04/25/13, 04/30/13 Discard After: 05/16/13, 05/21/13

Product
Baxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 3000mL bag, b) 5000mL bag and…
Recalling firm
Pentec Health
Quantity
5 Bags
Distribution
Dialysis Centers Direct to patient
Recall date
June 12, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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