Semifreddi’s Inc. of Alameda, CA is recalling all packaged Almond Biscotti and Chocolate Dipped Almond Biscotti because the food allergens milk and soy were not declared on the product labels. People who have an allergy or severe sensitivity to milk or soy run the risk of serious allergic reaction, including anaphylaxis, if they consume the products.
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FDA and NIH create first-of-kind Tobacco Centers of Regulatory Science
The U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) today, as part of an on-going interagency partnership, have awarded a total of up to $53 million to fund tobacco-related research in fiscal year 2013 to create 14 Tobacco Centers of Regulatory Science (TCORS).
Baxter Initiates Voluntary Recall of Two Lots of Dual Luer Lock Caps
Baxter International Inc. announced today it has initiated a voluntary recall of two lots of its Dual Luer Lock Caps (Product Code 2C6250, Lots 10043 and 10044) because of the presence of loose particulate matter found in the packaging. Particulate matter entering the fluid path from the Luer Lock Caps may result in thrombotic and embolic events, including: pulmonary embolism, myocardial infarction and stroke.
Wegmans Food Markets Issues Allergy Alert on Undeclared Soy (Allergen) in Wegmans Apple Cinnamon Mini Muffins, 14 oz.
Wegmans is recalling 4,327 units of Wegmans brand APPLE CINNAMON Mini Muffins, Net Wt. 14 oz., because the product contains undeclared soy. People who have an allergy to soy run the risk of serious or life-threatening allergic reaction if they consume this product.
Federal judge approves consent decree against Shamrock Medical Solutions Group
The U.S. Food and Drug Administration announced today that federal judge Algenon L. Marbley of the Southern District of Ohio has approved a consent decree of permanent injunction against Shamrock Medical Solutions Group, LLC, of Lewis Center, Ohio, and four of its corporate officers and employees for continued drug manufacturing and labeling violations that resulted in the distribution of mislabeled drugs.
FDA approves first generic capecitabine to treat colorectal and breast cancers
The U.S. Food and Drug Administration today approved the first generic version of Xeloda (capecitabine), an oral chemotherapy pill used to treat cancer of the colon or rectum (colorectal cancer) that has spread to other parts of the body (metastatic), and metastatic breast cancer.
FDA prohibits manufacture of FDA-regulated drugs from Ranbaxy’s Mohali, India, plant and issues import alert
The U.S. Food and Drug Administration today issued an import alert under which U.S. officials may detain at the U.S. border drug products manufactured at Ranbaxy Laboratories, Ltd.’s facility in Mohali, India. The firm will remain on the import alert until the company complies with U.S. drug manufacturing requirements, known as current good manufacturing practices (CGMP).
HeartSine Technologies, Ltd. Issues Global Correction of Samaritan® 300/300P PAD
HeartSine Technologies, Ltd. initiated a voluntary global correction of certain Samaritan® 300/300P PAD public access defibrillators to address two separate issues that may affect the ability to deliver therapy to a patient in a sudden cardiac arrest (SCA) event, if needed.
Dutch Valley Food Distributors, Inc. Announces a Voluntary Nationwide Recall of Honey Roasted Peanuts, for Undeclared Milk and Wheat
Myerstown, PA – September 12, 2013 – As a result of an internal review, Dutch Valley is issuing a recall on Honey Roasted Peanuts due to undeclared Milk and Wheat Ingredients. Individuals with food allergies to Milk and or Wheat may run the risk of a serious or life threatening allergic reaction if they consume these products.
Hospira Issues a Voluntary Nationwide Recall of One Lot of 0.25% Bupivacaine HCL Injection, USP (2.5 MG/ML), 30 ML Single-Dose Vial and One Lot of 0.75% Bupivacaine HCL Injection, USP (7.5 MG/ML), 30 ML Single Dose Vial Due to Presence of Particulate Matter
Hospira, Inc. (NYSE: HSP), announced today, on July 12, 2013, it initiated a voluntary nationwide recall to the user level for one lot of 0.25% Bupivacaine HCl Injection, USP (2.5 mg/mL), 30 mL Single-dose Vial (NDC 0409-1159-02). An expanded recall was issued on August 29, 2013 for one lot of 0.75% Bupivacaine HCl Injection, USP (7.5 mg/mL), 30 mL Single-dose Vial (NDC 0409-1165-02).