Reported Jun 12, 2013 · Terminated
Proplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 710mL 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 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 710mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
- Lot codes and dates
- Compounding Date04/24/13
- Discard after5/15/13
- Amount recalled
- 1 Bag
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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Pentec Health recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.