CLASS II Drug recall · Reported 12 Jun 2013 · FDA Enforcement Report
Fresenius bag 1% Amino Acids recalled by Pentec Health
Pentec Health is recalling Fresenius bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution. The recall was initiated on 15 May 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-584-2013
- FDA event ID
- 65180
- Recalling firm
- Pentec Health, Boothwyn, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 May 2013
- FDA classified
- 6 Jun 2013
- Reported
- 12 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 15 May 2013 | Recall initiated by company | |
| 6 Jun 2013 | Classified by FDA | +22 days |
| 12 Jun 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Fresenius bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), 1000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
Where it was distributed
Dialysis Centers Direct to patient
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions
Which lots are affected?
Compounding Date: 04/30/13 Discard after: 05/21/13
Where was it sold?
Dialysis Centers Direct to patient
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
14 other products · FDA event 65180This product is part of a recall event; the main page for the event is Proplete 34 - (Intradialytic Parenteral Nutrition composed recalled.
More recalls from Pentec Health
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Proplete 40 - (Intradialytic Parenteral Nutrition recalled | Pentec Health | Sterility | PA |
| Drug | CLASS II | Proplete 60 - (Intradialytic Parenteral Nutrition recalled | Pentec Health | Sterility | PA |
| Drug | CLASS II | IDPN (Intradialytic Parenteral Nutrition recalled by Pentec Health | Pentec Health | Sterility | PA |
| Drug | CLASS II | Proplete 52 - (Intradialytic Parenteral Nutrition recalled | Pentec Health | Sterility | PA |
| Drug | CLASS II | Proplete 70+ KG (Intraperitoneal Parenteral Nutrition recalled | Pentec Health | Sterility | PA |