Status
Terminated
Drug Enforcement D-595-2013
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 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 2500mL bag and b) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
- Product quantity
- 3 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-595-2013
- Event ID
- 65180
- Recall initiation date
- May 15, 2013
- Center classification date
- June 6, 2013
- Code info
- Compounding Date: a) 04/26/13, b) 04/30/13 Discard after: a) and b) 5/21/13
- More code info
- —