Recalls / Class II
Class IID-587-2013
Product
Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 485mL bag and b) 490mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
- Affected lot / code info
- Compounding Date: 04/24/13, 04/25/13, 04/29/13 Discard after: 05/15/13, 05/16/13, 05/20/13
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
- 25 Bags
- 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-587-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.