Drug Enforcement D-581-2013

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

Status

Terminated

Classification

Class II

Report Date

June 12, 2013

Termination Date

December 16, 2014

Product Information

Product description
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
Product quantity
1 Bag
Reason for recall
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Recall initiation reason
—
Initial firm notification
Telephone
Distribution pattern
Dialysis Centers Direct to patient

Location & Firm

Recalling firm
Pentec Health
Address
4 Creek Pkwy Ste A, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-581-2013
Event ID
65180
Recall initiation date
May 15, 2013
Center classification date
June 6, 2013
Code info
Compounding Date: 4/25/13 Discard after: 5/16/13
More code info
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