Pentec Health Inc. has initiated a limited recall of some of its nutritional prescriptions for renal patients due to lack of sterility assurance associated with one of its laminar flow hoods used in compounding. The recall covers renal therapies that were compounded in this hood on or before May 2, 2013. These therapies were supplied to renal dialysis centers and directly to patients. Pentec Health is directly notifying each dialysis center and in-home dialysis patient of the recall. Prescriptions for a total of 163 patients are included in the scope of this recall, Pentec Health said
The company said it has received no reports of injury or illness associated with any of the prescriptions subject to this recall. Sterility tests associated with the compounding hood involved, as well as testing of finished products made in the hood, have shown sterility. However the company said it is being extra cautious because patients are at increased risk of infection in the event a sterile product is compromised, the pharmacy is recalling any unused product whose beyond-use date has not passed.
Patients should experience little to no disruption in their therapy as a result of this limited recall.
Consumers or health care providers with questions regarding this recall may contact Pentec Health by phone at 800.223.4376, prompt 7, or e-mail at firstname.lastname@example.org. Patients who have received any prescriptions prepared by Pentec Health and have concerns should contact their health care provider.