Reported Jun 12, 2013 · Terminated
Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 485mL bag…
Pentec Health
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pentec Health · 4 Creek Pkwy Ste A · Boothwyn, PA · 19061-3132
Is this the product you have?
- 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
- Lot codes and dates
- Compounding Date
04/24/1304/25/1304/29/13
- Discard after
05/15/1305/16/1305/20/13
- Compounding Date
- Amount recalled
- 25 Bags
This recall covers 15 products
The agency filed one notice per product. You are reading one of them; the other 14 are below.
2 more are in the archive.
Why it was recalled
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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