CLASS II Drug recall · Reported 12 Jun 2013 · FDA Enforcement Report
Proplete 34 - (Intradialytic Parenteral Nutrition composed recalled
Pentec Health is recalling Proplete 34 - (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and. 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-581-2013
- 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
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
Where it was distributed
Dialysis Centers Direct to patient
Questions about this recall
Is Proplete 34 - (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and recalled?
Yes. Pentec Health recalled Proplete 34 - (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and on 15 May 2013. The recall is Class II and its status is Terminated. Recall number D-581-2013.
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: 4/25/13 Discard after: 5/16/13
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 |