Posted 05/17/2013]
ISSUE: Pentec Health, Inc. initiated a limited, voluntary recall of in-date nutritional prescriptions for renal patients due to lack of sterility assurance associated with one of its laminar flow hoods used in compounding. Pentec Health has received no reports of injury or illness associated with any of the prescriptions subject to this recall. However, 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.
BACKGROUND: These renal 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. The recall covers renal therapies that were compounded in this hood on or before May 2, 2013. Sterility tests associated with the compounding hood involved, as well as testing of finished products made in the hood, have shown sterility.
RECOMMENDATION: 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 atrecall@pentechealth.com, Monday through Friday, between 9:00 am and 8:00 pm EDT. Patients who have received any prescriptions prepared by Pentec Health and have concerns should contact their health care provider.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[05/15/2013- Firm Press Release - Pentec Health, Inc.]
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