On July 1, 2009, the Food and Drug Administration issued a public health advisory titled: FDA Requires New Boxed Warnings for the Smoking Cessation Drugs Chantix and Zyban.
FDA Public Health Advisory: Loss of Sense of Smell with Intranasal Cold Remedies Containing Zinc
On June 16, 2009, the Food and Drug Administration issued a public health advisory titled: Loss of Sense of Smell with Intranasal Cold Remedies Containing Zinc
FDA Public Health Advisory Potential Hazards of Skin Products Containing Numbing Ingredients for Relieving Pain from Mammography and Other Medical Tests and Conditions
Potential Hazards of Skin Products Containing Numbing Ingredients for Relieving Pain from Mammography and Other Medical Tests and Conditions: Overview Version
Cardiac Science Notifies AED Customers of Nationwide Voluntary Medical Device Correction
Cardiac Science Corporation [NASDAQ: CSCX] is initiating a voluntary field correction after it was determined certain automated external defibrillators (AEDs) may experience a rare product issue in which the AED may not be able to deliver therapy during a resuscitation attempt. Device failure may affect resuscitation of the patient, which could lead to serious adverse events or death. These AEDs have electronic components which may fail and the failure may not be detected by the device’s periodic self-tests.
IDS Sports Conducts a Voluntary Nationwide Recall of Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, and Ripped Tabs TR
IDS Sports announced today that it is
conducting a voluntary nationwide recall of five of the company’s dietary supplement products sold
under the following names: Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, and
Ripped Tabs TR.
The Food And Drug Administration (FDA) has notified IDS Sports that the recalled products contain the
following undeclared substances, which FDA considers to be steroids: “Madol,” “Turinabol,”
“Superdrol,” and/or “Androstenedione.”
Conagra Foods Issues Nationwide Allergy Alert on a Limited Number of 15 oz. Tubs of Blue Bonnet Light Spread
Today, ConAgra Foods, in cooperation with the U.S. Food and Drug Administration (FDA) is voluntarily recalling a limited number of 15 oz. tubs of Blue Bonnet Spread that were inadvertently mispackaged—the lid is for regular Blue Bonnet Spread and the tub portion describes the product as Blue Bonnet Light Spread. The product inside of the tub is regular Blue Bonnet Spread. As a result, the product tubs do not declare the allergen whey (milk), as an ingredient.
GMP Herbal Products, Inc. Issues a Voluntary Nationwide Recall of a Weight Loss Supplement Found to Contain Undeclared Drug Ingredients
Herbal Products, Inc. has been informed by the Food and Drug Administration (FDA) that Pai You Guo, a weight loss dietary supplement, sold and marketed by the firm contains undeclared drug ingredients. FDA lab analyses of dietary supplements distributed by the company were found to contain undeclared sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss; and phenolphthalein, a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States.
Synthes USA, Ti Synex II Vertebral Body Replacement – Class I Recall
Reports of loss of device height, which may result in nerve injury, increased pain, spinal compression fracture, failure of additional fixation, and/or need for surgery to modify the implanted device.
Edwards Lifesciences CardioVations EndoClamp Aortic Catheter – Class 1 Recall
Product, used during cardiopulmonary bypass procedures, may spontaneously rupture during surgery.
Hospira Issues Nationwide Voluntary Recall of Certain Lots of Liposyn™ and Propofol Products That May Contain Particulate Matter
Hospira, Inc. (NYSE: HSP), a global specialty pharmaceutical and medication delivery company, is voluntarily recalling 85 lots of Liposyn™ II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, Liposyn III 30% and 73 lots of Propofol Injectable Emulsion 1% products that begin with the lot numbers 79 and 80 because some of the containers may contain particulate matter. The source of the particulate matter has been identified as stainless steel equipment used in the manufacturing process.