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Recall Observatory FDA recall evidence

Drug product

Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 485mL bag and b) 490mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

D-587-2013

May 15, 2013

Class II

Product summary

Firm
Pentec Health
Event
Event 65180
Status
Terminated
Classification
Class II
Quantity
25 Bags
Official record key
drug-enforcement:D-587-2013

Official wording

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

Code information: Compounding Date: 04/24/13, 04/25/13, 04/29/13 Discard after: 05/15/13, 05/16/13, 05/20/13

Distribution pattern: Dialysis Centers Direct to patient

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility