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Recall Observatory FDA recall evidence

Drug 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

D-583-2013

May 15, 2013

Class II

Product summary

Firm
Pentec Health
Event
Event 65180
Status
Terminated
Classification
Class II
Quantity
5 Bags
Official record key
drug-enforcement:D-583-2013

Official wording

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

Code information: 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

Distribution pattern: Dialysis Centers Direct to patient

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility