The Illinois-based global medical products and services company Baxter International Inc. ( BAX ) announced a nationwide recall of CLINIMIX (Amino Acid in Dextrose) and CLINIMIX E (Amino Acid with Electrolytes in Dextrose with Calcium) injections due to the presence of a harmful matter. These injections are used as a caloric component and a protein source for parenteral nutrition.
If infused, the harmful matter in the product could lead to blockages of blood vessels, resulting in stroke, heart attack, or damage to other organs such as the kidney or liver. It could also lead to allergic reactions, irritation, and inflammation in tissues and organs. However, the company has not yet received any reports of adverse events associated with the problem till date.
The product codes involved in the recall are 2B7729 (lot P287045, exp 06/14), 2B7717 (lot P275883, exp 10/13) and 2B7709 (lot P285122, exp 05/14). They were distributed to healthcare centers and distributors in the U.S. between May 2012 and Oct 2013.
Recently, BAX announced that it has received U.S. Food and Drug Administration (FDA) approval for its FEIBA (Anti-Inhibitor Coagulant Complex) treatment as well as CE marking in Europe for the VIVIA hemodialysis (HD) system.
FEIBA is the first and only FDA-approved treatment for routine prophylaxis that controls the frequency of bleeding episodes in hemophilia A or B patients, who have developed inhibitors. Inhibitors are antibodies produced by the body's immune system in response to factor replacement treatment. About one-third of previously untreated patients with hemophilia A are at risk of developing inhibitors.
VIVIA hemodialysis system is capable of delivering frequent, extended duration, short daily or nocturnal home HD therapy, known as High Dose HD therapy1. It is designed with the patient as the primary operator.
In November last year, Baxter entered a global licensing agreement with Cell Therapeutics, Inc. ( CTIC ) to jointly develop and commercialize JAK2/FLT3 inhibitor pacritinib that fights against genetic mutations linked to myelofibrosis, leukemia and some tumors. As per the agreement, BAX gained the commercialization rights for all indications for pacritinib outside the U.S. while it jointly commercializes with CTIC in the U.S.
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