August 15th, 2014
Voluntary Recall: Peritoneal Dialysis Solution
Baxter announced today that it is in the process of recalling two lots of peritoneal dialysis solution.
The drug, DIANEAL Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000 mL (Ambu-Flex II), is used for chronic renal failure patients.
The voluntary recall is due to the presence of oxidized stainless steel, garment fiber, and PVC particulate matter. The company has received no reports of adverse events, but administration of the product with the particulate matter could lead to local inflammation, adhesion formation, and could potentially lead to a fatal infection.
The following lots, distributed between May 30, 2014 and July 9, 2014, are being recalled:
Product Code NDC Number Lot # Expiration Date
L5B5202 0941-0457-05 C940700 May 31, 2016
L5B5202 0941-0457-05 C940841 May 31, 2016
Reference:
1. Baxter Voluntarily Initiates U.S. Recall of Two Lots of Peritoneal Dialysis Solution Due to Presence of Particulate Matter [press release]. 2014 Aug 13.
- September 10th, 2014
FDA Staff: Novo Nordisk Drug Liraglutide Effective for ObesityRead - August 12th, 2012
Statins and Risk of Treated Incident Diabetes in a Primary Care PopulationRead - June 3rd, 2014
(FINALLY) STOPPING STATINS MAY BENEFIT TERMINALLY ILL PATIENTSRead - November 8th, 2015
Study Finds Drug Errors in 50% of SurgeriesRead - December 31st, 2012
Managing Disruptive Doctors (or How to Handle a Spoiled Brat)Read
Geriatric Nutrition
Without good nutrition, positive drug therapy outcomes are very difficult to obtain, For the best in Geriatric Nutritional Information
Find out more Optima SolutionsContinuing Education
Each month we will post an analysis of specific aspects of government long-term healthcare regulations.
Find out more