Baxter voluntarily recalls select lots of premix parenteral nutrition

January 7, 2014

Baxter International has initiated a voluntary recall in the United States of 2 lots of premixed sterile intravenous (IV) parenteral nutrition products: CLINIMIX (Amino Acid in Dextrose) Injection and CLINIMIX E (Amino Acid with Electrolytes in Dextrose with Calcium) Injections to the user level because of complaints of particulate matter found in the products.

Baxter International has initiated a voluntary recall in the United States of 2 lots of premixed sterile intravenous (IV) parenteral nutrition products: CLINIMIX (Amino Acid in Dextrose) Injection and CLINIMIX E (Amino Acid with Electrolytes in Dextrose with Calcium) Injections to the user level because of complaints of particulate matter found in the products.

If infused, particulate matter may result in blockages of blood vessels, which can result in stroke, heart attack, or damage to other organs such as the kidney or liver. Allergic reactions, local irritation, and inflammation in tissues and organs, are also possible. There have been no reported adverse events associated with this issue to date, and the root cause of this voluntary recall has been identified and resolved. 

CLINIMIX and CLINIMIX E Injections come in multichambered containers and are used as a caloric component and as a protein source in a parenteral nutrition program. The affected product codes are 2B7729 (lot P287045, exp 06/14), 2B7717 (lot P275883, exp 10/13) and 2B7709 (lot P285122, exp 05/14). Affected products were distributed to healthcare centers and distributors in the United States. 

“These parenteral nutrition help to sustain the lives of many patients,’ according to Abimbola Farinde, PharmD, MS, who serves on the faculty at Columbia Southern University, Orange Beach, Ala. “The recall of CLINIMIX and CLINIMIX E Injection due to particulate matter being found in the products can be viewed as an appropriate safety measure on the part of Baxter and FDA to ensure that potential harm does not come to patients who are currently using the products.”

Baxter has notified customers, who are being directed not to use product from the recalled lots. Customers should locate and remove all affected product from their facility. The affected lots were distributed to customers between May 2012 and October 2013. Unaffected lot numbers can continue to be used according to the instructions for use. Affected product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at (888) 229-0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m., Central Time. Unaffected lots of product are available for replacement. 

Consumers with questions regarding this recall can call Baxter at (800) 422-9837, Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time, or e-mail Baxter at onebaxter@baxter.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product. 

Adverse reactions or quality problems experienced with the use of this product may be reported to 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: (800) FDA-0178