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:5/25/2016)... , May 25, 2016 ... Market by Type (3D, 2D, 4D), by Therapeutic Area ... by End User (Medical Device Manufacturers, Hospitals/ Clinics) - ... the global Medical Animation Market for the forecast period ... reach USD 301.3 Million by 2021 from USD 117.3 ...
(Date:5/25/2016)...  Zymo Research Corp. announced today the final ... that help researchers obtain the most accurate and ... rapid growth of the study of microbiomes has ... methods to improve the reproducibility and quality of ... every step of the measurement process including collection ...
(Date:5/25/2016)... 2016 As illustrated by the ... month, the numbers and momentum of cannabis in the ... the billions, more research and development push the sector ... of Legal Marijuana Markets Report  from from ArcView Market ... of the increase in sector is attributed to adult ...
Breaking Medicine Technology:
(Date:5/27/2016)... ... May 27, 2016 , ... Aimed at nurses ... human interest stories, courtesy of leaders in the nursing and health care industry. ... from leading advocates and associations—namely Jones & Bartlett Learning. , Jones & Bartlett ...
(Date:5/27/2016)... ... ... With a team of certified experts, Validation Center is ... GMP accreditation, Validation Center is also a registered authority of the international system ... Validation Center is ISO17025 accredited and only offers its clients the latest technology, ...
(Date:5/26/2016)... ... May 26, 2016 , ... W.S. Badger Co. Inc ., the maker ... 2016 When Work Works Award for its use of effective workplace strategies to increase ... Works project administered by the Families and Work Institute (FWI) and the Society for ...
(Date:5/26/2016)... ... May 26, 2016 , ... ... property (IP) to its specialty academic programs. , Answering to the increasing demand ... certificate programs in health law, and environmental and land use law. ,  , ...
(Date:5/26/2016)... ... , ... The Woodlands at John Knox Village , Florida’s first Life ... living and healing, celebrated its grand opening, today. The Woodlands at John Knox Village ... Empowered Staff. , “This is an incredibly fulfilling time for John Knox Village as ...
Breaking Medicine News(10 mins):