(NASDAQ: CBST) today announced it is voluntarily recalling one lot of CUBICIN® (daptomycin for injection) to the user level due to the presence of particulate matter, reported via customer complaint and identified as glass particles, found in a single vial from this lot, produced by a contract manufacturer. The administration of glass particulate, if present in an intravenous drug, poses a potential safety risk to patients.
Nature’s Universe Issues Voluntary Worldwide Recall of All Thinogenics Products Sold Prior to 02/06/2014 Due to the Presence of Undeclared Sibutramine
Nature’s Universe is voluntarily recalling all lots of old Thinogenics product (product sold prior to February 6, 2014, hereinafter the “Old Product”) to the user level after FDA analysis revealed that the Old Product contained undeclared sibutramine.
Hospira Announces Nationwide Voluntary Recall of Seven Lots of Propofol Injectable Emulsion, USP, Due to Visible Particulates
Hospira, Inc. (NYSE: HSP), announced today that on April 2, 2014, it informed customers of a nationwide recall of seven lots of Propofol Injectable Emulsion, USP, to the user level due to a glass defect located on the interior neck of the vial, which was identified during a retain sample inspection where the glass vial contained visible embedded metal particulate. Free-floating metal particulates were also identified in vials upon further analysis.
FDA approves Ragwitek for short ragweed pollen allergies
The U.S. Food and Drug Administration today approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflammation), in adults 18 years through 65 years of age.
FDA discourages use of laparoscopic power morcellation for removal of uterus or uterine fibroids
In a safety communication notice issued today, the U.S. Food and Drug Administration discouraged the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) in women because, based on an analysis of currently available data, it poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.
Price Chopper Supermarkets Recalls Price Chopper Brand Tuscan White Bean Hummus due to Mislabeling
Price Chopper Supermarkets is issuing a voluntary recall on its Price Chopper Brand Tuscan White Bean Hummus. The product is being recalled due to it being mislabeled with the ingredient panel for Price Chopper Sweet Potato Hummus, which does not declare that the product contains parmesan cheese, a known allergen.
Natural Organics, Inc. Recalls one lot ofTHURSDAY PLANTATION TEA TREE MOUTHWASH Due to Bacterial Contamination
Natural Organics, Inc. is expanding its April 3, 2014 recall of distributed Thursday Plantation Tea Tree Mouthwash to Lot 10952 after they were notified by its contract manufacturer INTEGRIA Healthcare (Australia} Pty Ltd. that this second lot of Tea Tree Mouthwash failed microbial contamination testing due to potential bacterial contamination.
This bacterial contaminant, Pseudomonas aeruginosa, could pose a health risk to consumers.
Puerto Rico bakery agrees to stop manufacturing and distributing products
Los Genuinos, Inc., a Bayamon, Puerto Rico, food manufacturer, has agreed under terms of a court order not to process or distribute food until it addresses the unsanitary conditions found by U.S. Food and Drug Administration investigators. The company must also correct its product labels to accurately reflect the ingredients used in its products.
Health Matters America Inc. Issues Allergy Alert on Undeclared Milk in Organic Traditions Brand Dark Chocolate Golden Berries and Dark Chocolate Sacha Inchi Seeds
HEALTH MATTERS AMERICA INC. of Cheektowaga, New York is recalling specific lots of ORGANIC TRADITIONS BRAND DARK CHOCOLATE GOLDEN BERRIES AND DARK CHOCOLATE SACHA INCHI SEEDS because they were found to contain undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
Purina Animal Nutrition LLC Recalls Poultry Feeds Due to Potential Health Risk
The Purina Animal Nutrition LLC feed plant in Portland, Ore., has initiated a limited recall of certain poultry feeds due to the potential for lower-than-expected vitamin and trace mineral levels. The products were distributed to retailers in Oregon and Washington.