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FDA approves first treatment for rare disease in patients who receive stem cell transplant from blood or bone marrow

The U.S. Food and Drug Administration today approved Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive disease (VOD) with additional kidney or lung abnormalities after they receive a stem cell transplant from blood or bone marrow called hematopoietic stem cell transplantation (HSCT). This is the first FDA-approved therapy for treatment of severe hepatic VOD, a rare and life-threatening liver condition.

FDA allows use of investigational test to screen blood donations for Zika virus

The U.S. Food and Drug Administration today announced the availability of an investigational test to screen blood donations for Zika virus. The screening test may be used under an investigational new drug application (IND) for screening donated blood in areas with active mosquito-borne transmission of Zika virus.

B. Braun Medical Inc. Issues Voluntary Nationwide Recall of Lot J5J706, 5% Dextrose Injection USP in PAB Container Due to Leakage and/or Particulate Matter Identified To Be Microbial Growth

B. Braun Medical Inc. of Irvine, CA is voluntarily recalling one lot of 5% Dextrose Injection USP 100/150mL container (Lot #J5J706, catalog # S5104-5264, NDC 0264-1510-32) to the consumer level. B. Braun recently identified an adverse quality trend in customer complaints reporting that some containers in lot J5J706 exhibited leakage and, in a few instances, visible particulate matter identified to be microbial growth.

Gerber is Voluntarily Recalling Two Batches of GERBER® Organic 2ND FOODS® Pouches Due to a Packaging Defect That May Result in Product Spoilage

Gerber Products Company is voluntarily recalling specific Organic pouch products after identifying a packaging defect that may result in product spoilage during transport and handling. Because of our commitment to high quality, Gerber is working to retrieve from retailers and online stores the remaining pouches from the four affected batches of GERBER® Organic 2ND FOOD pouches that fail to meet our quality standards. We are offering replacement coupons for consumers who purchased the following products: