Hospira, Inc., (NYSE: HSP) has announced a voluntary recall of one lot of Magnesium Sulfate in 5% Dextrose, Inj., USP, 10 mg/mL (NDC: 0409-6727-23, Lot 42-120-JT, Expiry 1DEC2015) to the user level due to confirmed customer reports of an incorrect barcode on the primary bag labeling. The barcode on the overwrap is correct; however, there is potential for the primary container barcode to be mislabeled with the barcode for Heparin Sodium 2000 USP units/1000 mL in 0.9% Sodium Chloride Inj. The product is labeled with the correct printed name on the primary container and overwrap.
FDA authorizes use of first device to treat patients with dialysis-related amyloidosis
The U.S. Food and Drug Administration today authorized use of Lixelle Beta 2-microglobulin Apheresis Column, the first device to treat dialysis-related amyloidosis (DRA).
FDA approves first biosimilar product Zarxio
The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the U.S.
Hospira Issues A Voluntary Nationwide Recall of One Lot of 0.9% Sodium Chloride Injection, USP, 250 mL VisIV Container Due to Particulate Matter
Hospira, Inc. (NYSE: HSP), announced today that it will initiate a voluntary nationwide recall of one lot of 0.9% Sodium Chloride Injection, USP, 250 mL VisIV flex container (NDC 0409-7983-25, Lot 45-110-C6, Expiry 1MAR2016) to the user level due to one confirmed customer report of particulate in a single unit. The foreign particle was confirmed by Hospira as human hair free-floating within the solution.
FDA expands approved use of Opdivo to treat lung cancer
The U.S. Food and Drug Administration today expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
Maternal Science, Inc. Issues Allergy Alert on Undeclared Milk in healthy mama® Boost It Up!tm Mango Drink
Maternal Science, Inc. of Montvale, NJ, is voluntarily recalling healthy mama® Boost It Up!tm Drink because it contains undeclared milk (whey protein isolate). People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume this product.
FDA launches drug shortages mobile app
Today, the U.S. Food and Drug Administration launched the agency’s first mobile application (app) specifically designed to speed public access to valuable information about drug shortages.
Ateeco, Inc., Maker of Mrs. T’s Pierogies, Issues Voluntary Regional Product Recall of Mozzarella, Tomato & Basil Pierogies Due to Plastic Contamination
On February 27, 2015, Mrs. T’s Pierogies, of Shenandoah, PA, announced the voluntary recall of specific lots of its Mozzarella, Tomato & Basil variety of pierogies, due to safety concerns. The affected product was distributed to a limited number of retail customers and is being recalled due to plastic contamination in the product which may be a choke hazard.
Talenti Gelato & Sorbetto Issues Allergy Alert for Limited Number of Jars of Talenti Gelato & Sorbetto Sea Salt Caramel Gelato Due to Undeclared Peanut
Talenti Gelato & Sorbetto, a Unilever company, is voluntarily recalling a limited number of jars of Talenti Gelato & Sorbetto Sea Salt Caramel Gelato because they may inadvertently contain peanuts (as peanut butter), which are not listed as an ingredient on the label. Persons who have an allergy or severe sensitivity to peanuts run the risk of a serious or life-threatening allergic reaction if they consume this product.
Heartware International Recalls Certain Older Heartware Clinical Trial Controllers
HeartWare International, Inc. (Nasdaq: HTWR), is issuing a voluntary Urgent Medical Device Recall in the United States related to older HeartWare Ventricular Assist System Controllers, which were distributed in the U.S. during the clinical trial period prior to Food and Drug Administration (FDA) approval in 2012. HeartWare has commenced this field action in other countries in recent weeks.