AUDIENCE: Consumer, Pharmacy, OB/GYN ISSUE: Qualitest Pharmaceuticals issued a nationwide, retail-level recall of multiple lots of oral contraceptives because a packaging error may result in the daily regimen for these products being incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy. Select blisters were rotated 180 degrees within the card, [...]
Magic Power Coffee, an instant coffee product marketed as a dietary supplement for sexual enhancement, contains the drug ingredient hydroxythiohomosildenafil, a chemical similar to sildenafil, the active ingredient in Viagra. Hydroxythiohomosildenafil, like sildenafil, may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure. FDA is warning consumers not to [...]
WASHINGTON, D.C. – The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed. Name of Product: Vicks Dayquil Cold & Flu 24-Count Bonus Pack Liquicaps Units: About 700,000 packages Manufacturer: The Procter [...]
Kunze Farms of Dayton, Oregon is recalling 32,950 lbs. of hazelnut kernels because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which [...]
The Medicines Company (NASDAQ: MDCO) announced today that it is voluntarily recalling eleven (11) lots of Cleviprex ® (clevidipine butyrate) injectable emulsion due to the potential presence of visible particulate matter which has been observed in some vials during a routine annual inspection. The affected Cleviprex lots are 61-978-DW, 61-979-DW, and 61-980-DW, Exp. 01/2010; 68-404-DJ, [...]
GMP Herbal Products and FDA notified consumers and healthcare professionals of a recall of Pai You Guo, a weight loss dietary supplement, due to the presence of undeclared drug ingredients. FDA lab analyses of dietary supplements were found to contain undeclared sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss; and phenolphthalein, a [...]
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 [...]
Edwards Lifesciences CardioVations EndoClamp Aortic Catheter – Class 1 FDA and Edwards Lifesciences notified healthcare professionals about the Class 1 recall of CardioVations EndoClamp Aortic Catheter, Model Numbers EC1001 and EC65, a device that blocks off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures. The recall was [...]
Bodybuilding.com and FDA notified healthcare professionals and patients of a nationwide and international recall of all lots and expiration dates of 65 dietary supplement products that were sold through the Company’s website, www.bodybuilding.com. FDA believes that the recalled products contain the following ingredients that are currently classified, or the FDA believes should be classified, as [...]
PLEASE NOTE: This recall is in addition to the voluntary recall initiated on October 16, 2009 when American Regent voluntarily recalled ALL unexpired lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL due to the presence of particulate matter in conjunction with crystallization. This voluntary recall is due to the potential that particulates from crystallization may [...]