Status
Terminated
Drug Enforcement D-587-2013
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Classification
Class II
Report Date
June 12, 2013
Termination Date
December 16, 2014
Product Information
- Product description
- 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
- Product quantity
- 25 Bags
- Reason for recall
- Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Dialysis Centers Direct to patient
Location & Firm
- Recalling firm
- Pentec Health
- Address
-
4 Creek Pkwy Ste A, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-587-2013
- Event ID
- 65180
- Recall initiation date
- May 15, 2013
- Center classification date
- June 6, 2013
- Code info
- Compounding Date: 04/24/13, 04/25/13, 04/29/13 Discard after: 05/15/13, 05/16/13, 05/20/13
- More code info
- —