Reported Jun 12, 2013 · Terminated
Baxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a)…
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?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 3000mL bag |
| 2 | 5000mL bag and |
| 3 | 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132 |
- Lot codes and dates
- a) Compounding Date04/30/13
- Discard After05/21/13
- b) Compounding Date04/30/13
- Discard After05/21/13
- c) Compounding Date
04/25/1304/30/13
- Discard After
05/16/1305/21/13
- Amount recalled
- 5 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.
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.
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