Pentec Health announced a voluntary recall of in-date nutritional prescriptions for renal patients due to a lack of sterility assurance with one of its laminar flow hoods used in compounding. The pharmacy is recalling any unused product compounded on or before May 2, 2013, due to the increased risk of infection if a sterile product is compromised.
The renal therapies were supplied to renal dialysis centers and to patients. A total of 163 patients’ prescriptions are affected by this recall. Sterility tests associated with the compounding hood involved, as well as testing of finished products made in the hood, have shown sterility.
Pentec Health is notifying each dialysis center and in-home dialysis patient of the recall.
For more information call (800) 223-4376 or visit FDA.gov.