Status
Terminated
Drug Enforcement D-583-2013
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
- Baxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 3000mL bag, b) 5000mL bag and c) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
- Product quantity
- 5 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-583-2013
- Event ID
- 65180
- Recall initiation date
- May 15, 2013
- Center classification date
- June 6, 2013
- Code info
- a) Compounding Date: 04/30/13 Discard After: 05/21/13 b) Compounding Date: 04/30/13 Discard After: 05/21/13 c) Compounding Date: 04/25/13, 04/30/13 Discard After: 05/16/13, 05/21/13
- More code info
- —