Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Pentec Health Announces Limited Voluntary Recall of Certain Compounded Prescription Therapies for Renal Patients
(800) 223-4376, prompt 7
FOR IMMEDIATE RELEASE - May 15, 2013 - Pentec Health, Inc. has decided to initiate 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.
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 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, in an abundance of caution, 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, 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.
Adverse reactions or quality problems experienced with the use of any of the recalled drugs may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Online: www.fda.gov/medwatch/report.htm
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at:
www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
- Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
For further information: Lisi Christofferson, APCO Worldwide, 202 659-7918.