Navigation Links
Pentec Health Announces Limited Voluntary Recall of Certain Compounded Prescription Therapies for Renal Patients
Date:5/16/2013

BOOTHWYN, Pa., May 16, 2013 /PRNewswire-USNewswire/ -- 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 recall@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.

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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.


'/>"/>
SOURCE Pentec Health, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Nutrilys Del Mar Joins Health Forces With LAPD Underwater Dive Unit
2. Clinical Trial at Evergreen Healthcare Shows Intestinal Gel Reduces Symptoms of Advanced Parkinsons Disease
3. Netsmarts Focus on Innovation to Help Health and Human Service Providers Span the Spectrum of Care in the Healthcare 3.0 Environment
4. Qmed, the Leading Global MedTech Industry Resource, Partners with Clarimed, to Provide the Medical Manufacturing and Healthcare Industry with FDA Reports on Adverse Events
5. Attendees Save Up To $800 on Global Healthcare Conferences in 2012 by Registering Through Global Information Inc.
6. Auxilium Pharmaceuticals to Present at the Deutsche Bank 37th Annual Healthcare Conference
7. University of Maryland BioPark Announces MedImmunes Dr. Bahija Jallal as Newest Member of Board of Directors for UM Health Sciences Research Park
8. Genomic Health to Announce First Quarter 2012 Financial Results and Host Conference Call on Wednesday, May 2, 2012
9. Nearly 300 Medical Device, Healthcare Professionals Attend First National Conference on Value-driven Engineering
10. Varian Medical Systems and Siemens Healthcare Announce Global Collaboration to Advance Clinical Capabilities and Offerings in Radiotherapy and Radiosurgery
11. Med Ad News Honors Healthcare Communication Agencies at 23rd Annual Manny Awards
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/10/2017)... , May 10, 2017 Global Health ... Latin America , published its 2017 ranking ... ranking is based on extensive data analysis from GHI,s ... largest hospitals database for the region. The GHI database covers ... , offering more than 130 data points for each institution ...
(Date:5/10/2017)... 2017 CSSi, the global leader in patient ... industry, is proud to announce the launch of its ... features both enriched content and a customized layout that ... company,s already well-established position as the top global patient ... many months of hard work, we are delighted to ...
(Date:5/9/2017)... 2017  Oramed Pharmaceuticals Inc. (NASDAQ: ... company focused on the development of oral drug ... Property Office has granted Oramed a patent titled, ... The patent covers Oramed,s invention of an oral ... an incretin hormone that stimulates the secretion of ...
Breaking Medicine Technology:
(Date:5/23/2017)... ... May 23, 2017 , ... London, May 23, 2017: Walter Schindler, the ... month as a Guest Speaker and Contributor to a weeklong series of classes, meetings, ... , Walter Schindler and SAIL Capital have received an ...
(Date:5/23/2017)... New York (PRWEB) , ... May 23, 2017 ... ... NextGen LifeLabs, a leading equipment provider in the modern ART laboratory, to provide ... Institute in Ft. Lauderdale, Florida. , NextGen LifeLabs, a MedTech Group Purchasing ...
(Date:5/23/2017)... , ... May 23, 2017 , ... New patients with ... chronic bad breath, can now receive laser gum disease treatments from the doctors at ... and David Landau are raising awareness of the importance of receiving qualified treatment in ...
(Date:5/22/2017)... ... 2017 , ... The American Academy of Thermology ... and clinical application of medical infrared imaging, has announced two new educational offerings ... services. , The first new educational offering is an online self-directed Physician Member ...
(Date:5/22/2017)... ... ... An inventor from Columbia, S.C., wants to offer people with manual disabilities ... a firework accident, so she couldn’t grip a pen properly," he said. "This inspired ... and created a prototype for the HELPEN HAND, a special pen that enables a ...
Breaking Medicine News(10 mins):