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.
Category Archives: Food & Drug Recalls
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.
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).
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.
New medical device treats urinary symptoms related to enlarged prostate
The U.S. Food and Drug Administration today authorized the marketing of the UroLift system, the first permanent implant to relieve low or blocked urine flow in men age 50 and older with an enlarged prostate.
GE Pharma, LLC Announces a Recall of Dietary Supplement Creafuse Powder Due to Possible Health Risk
Ge Pharma, LLC of North Haven, CT is recalling Creafuse Powder Grape Lot# GE4568 and Creafuse Powder Fruit Punch Lot #GE4570, packaged in a white, 600 gram container with an expiration date of 2/2015 because it contains 1,3 dimethylamylamine (DMAA). DMAA is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products.
Schwebel Baking Company Voluntarily Recalls Schwebel’s Golden Rich Buns With Honey Due to Undeclared Eggs
Schwebel Baking Company today recalled 18,979 units of Golden Rich Buns with Honey due to mislabeling and undeclared egg. Through the package validation process the problem was discovered.
FDA approves Botox Cosmetic to improve the appearance of crow’s feet lines
The U.S. Food and Drug Administration today approved a new use for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of moderate to severe lateral canthal lines, known as crow’s feet, in adults. Botox Cosmetic is the only FDA approved drug treatment option for lateral canthal lines.