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FDA Recalls Parenteral Nutrition Products Clinimix and Clinimix E
Agency cites complaints of particulate matter (January 6)
The FDA has notified health professionals and their medical care organizations of a voluntary recall in the U.S. of two lots of Clinimix (amino acid in dextrose) injection and one lot of Clinimix E (amino acid with electrolytes in dextrose with calcium) injection parenteral nutrition products because of 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.
Clinimix and Clinimix E injections are premixed sterile intravenous parenteral nutrition products that come in multichambered containers. Both products are used as a caloric component and as a protein source in a parenteral nutrition program. The products are manufactured by Baxter International.
Baxter has directed customers not to use products from the recalled lots and to locate and remove all affected products from their facility.
According to the product labeling, parenteral drug products should be inspected visually for particulate matter and discoloration whenever the solution and container permit. The use of a final filter is recommended during the administration of all parenteral solutions, where possible.
Source: FDA; January 6, 2013.