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Recall Observatory FDA recall evidence

Drug product

Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and sterile water), in 330mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-13132

D-581-2013

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-581-2013

Official wording

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

Code information: Compounding Date: 4/25/13 Discard after: 5/16/13

Distribution pattern: Dialysis Centers Direct to patient

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility