Baxter Recalls Peritoneal Dialysis Solution - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Baxter Recalls Peritoneal Dialysis Solution


Baxter International announced it is voluntarily initiating a recall in the US of two lots of DIANEAL Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000mL (Ambu-Flex II) to the hospital/user level. The recall is being initiated because of the presence of oxidized stainless steel, garment fiber, and PVC particulate matter identified during the manufacturing process.

According to the company, no adverse events or related product complaints have been associated with the recalled products, which were distributed to dialysis centers, facilities, distributors, and patients in the US.

Intraperitoneal administration of a product with particulate matter may cause local inflammation with foreign body reaction or result in adhesion formation. The particulate matter could potentially serve as a focal point for infection should any pre-existing peritonitis exist, and may lead to a fatal outcome.

DIANEAL is a peritoneal dialysis (PD) solution for use in chronic renal failure patients being maintained on peritoneal dialysis therapy. PD therapy is performed by using the body’s peritoneal membrane as a filter, while special solution and osmotic pressure help remove extra fluids and clean the blood. This process takes the place of what healthy kidneys do for the body.

Source: FDA.gov

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality

Click here