CLINIMIX and CLINIMIX E Injection/Baxter: Recall - Particulate Matter in Products

[Posted 01/06/2014]

AUDIENCE: Pharmacy, Risk Manager

ISSUE: Baxter International and FDA notified health professionals and their medical care organizations of a voluntary recall in the United States of two lots of CLINIMIX and one lot of CLINIMIX E Injection parenteral nutrition products due to complaints of particulate matter found in the products. The affected product codes are 2B7729 (lot P287045, exp 06/14), 2B7717 (lot P275883, exp 10/13) and 2B7709 (lot P28512, exp 05/14). The affected lots were distributed to customers between May 2012 and October 2013.

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. There is also the possibility of allergic reactions, local irritation, and inflammation in tissues and organs.

BACKGROUND: CLINIMIX (Amino Acid in Dextrose) Injection and CLINIMIX E (Amino Acid with Electrolytes in Dextrose with Calcium) Injections are premixed sterile intravenous (IV) parenteral nutrition products that come in multi-chambered containers and are used as a caloric component and as a protein source in a parenteral nutrition program.

RECOMMENDATION: Baxter has notified customers, who have been directed not to use product from the recalled lots and to locate and remove all affected product from their facility.

According to the product labeling, parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit. The use of a final filter is recommended during administration of all parenteral solutions where possible.

[01/03/2014 - Press Release - Baxter]