Two lots of CLINIMIX and one lot of CLINIMIX E Injection parenteral nutrition products have been recalled by Baxter due to 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. There is also the possibility of allergic reactions, local irritation, and inflammation in tissues and organs. 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 (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. 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 Sates.
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.
See the Recall
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication