Recalls / Class II
Class IID-591-2013
Product
Proplete 90+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 805mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
- Affected lot / code info
- Compounding Date: 04/23/13 Discard after: 5/15/13
Why it was recalled
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Recalling firm
- Firm
- Pentec Health
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 4 Creek Pkwy Ste A, N/A, Boothwyn, Pennsylvania 19061-3132
Distribution
- Quantity
- 1 Bag
- Distribution pattern
- Dialysis Centers Direct to patient
Timeline
- Recall initiated
- 2013-05-15
- FDA classified
- 2013-06-06
- Posted by FDA
- 2013-06-12
- Terminated
- 2014-12-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-591-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.