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Recall Observatory FDA recall evidence

Drug product

Baxter LL bag 1% Amino Acids w/KCL (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids and KCL), in 3000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132

D-593-2013

May 15, 2013

Class II

Product summary

Firm
Pentec Health
Event
Event 65180
Status
Terminated
Classification
Class II
Quantity
1 Bag
Official record key
drug-enforcement:D-593-2013

Official wording

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

Code information: Compounding Date: 04/29/13 Discard after: 5/21/13

Distribution pattern: Dialysis Centers Direct to patient

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility