Penumbra Neuron 5F Select Catheter
September 12, 2009
Penumbra and FDA notified healthcare professionals of the Class 1 recall of the Neuron 5F Select Catheter, used to remove blood clots or foreign objects from blood vessels. Due to a manufacturing error, the catheters may contain pin holes and exposed wire braids which may result in a brain clot or a blood vessel puncture, and this may lead to possible death. The device was distributed from May 5, 2009 through June 12, 2009.
Qualitest Pharmaceuticals Recalls Accusure Insulin Syringes
August 22, 2009
Qualitest Pharmaceuticals, Inc., has issued a voluntary nationwide recall of Accusure® Insulin Syringes (1/2 cc – 31 G – Short Needle) with lot number 6JCB1 (Expiration 10/2011) – NDC 0603-7001-21. This lot was distributed between January 2007 and June 2007 to wholesalers and retail pharmacies nationwide (including Puerto Rico). Also today, Qualitest has issued a voluntary nationwide recall of Accusure® Insulin Syringes (1 cc – 31 G –Short Needle) with lot number 7CPT1 (Expiration 03/2012) – NDC 0603-7002-21 This lot was distributed between May 2007 and June 2008 to wholesalers and retail pharmacies nationwide (including Puerto Rico). The syringes in these lots have been found to have needles which can detach from the syringe.
Nutracoastal Trading LLC Expands Its Voluntary Nationwide Recall Of Steam Dietary Supplement
August 19, 2009
Hospira Issues Urgent Device Recall For AC Power Cords
August 15, 2009
Hospira, Inc. (NYSE: HSP), is initiating a nationwide recall of certain Hospira devices that have defective AC power cords manufactured by Electri-Cord Manufacturing Corporation. This recall is being issued in response to customer reports of sparking, charring and fires on the plug of the power cord. Hospira’s investigation of these reports determined that the power cord’s prongs may crack and fail at or inside the plug. The potential risks from this power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires which may also occur in an oxygen-rich environment. Depending on the device and therapy, these failures may lead to potential serious injury or death. The products affected by this recall include:
Barr Laboratories Issues Nationwide Recall of Certain Dextroamphetamine Amphetamine 20mg Tablets
August 15, 2009
Barr Laboratories, Inc. has recalled Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of a Single Entity Amphetamine Product) 20mg Tablets, 100 count bottles, lot number 311756. The product identified is being recalled because the affected lot may contain some tablets exceeding weight requirements which may lead to super-potent tablets.
Carefusion Issues Update Regarding Previously Disclosed Recall of the Alaris
July 31, 2009
CareFusion Corporation, which is expected to become a public company following its planned spinoff from Cardinal Health, today issued the following update regarding its previously disclosed recall of the Alaris System:
Abbott Issues Voluntary Recall of POWERSAIL Coronary Dilatation Catheters
July 31, 2009
Abbott has conducted a voluntary recall of three lots of POWERSAIL® Coronary Dilatation Catheters from United States distribution and one lot from international distribution as a result of four complaints (one from each lot) that the distal shaft of the catheter exhibited damage. While the issue could be detected and avoided during the preparation for use of the product, it may cause a leak of contrast material during use, which could lead to catheter functional failures and clinical consequences, including air embolism and myocardial infarction, which has the potential to lead to death.
Nutracoastal Trading Recalls STEAM Dietary supplement lot 80214
July 30, 2009
Nutracoastal Trading LLC announced today that it is conducting a voluntary nationwide recall of the company’s dietary supplement product sold under the following name: STEAM.
Nutracoastal Trading Recalls S-DROL Dietary supplement lot 810481
July 30, 2009
Nutracoastal Trading LLC announced today that it is conducting a voluntary nationwide recall of the company’s dietary supplement product sold under the following name: S-DROL.
Celeste Industries Recalls simplySmart Remove Make Up Remover
July 21, 2009
Celeste Industries Corporation has voluntarily recalled all lots of simplySmart “Remove” Make Up Remover in the US and Canada. This product is packaged as a single towelette with hiexpress.com shown on the packet. This recall was a result of certain limited lots testing positive for Pseudomonas aeruginosa bacteria.
Wirth’s Nutcracker Sweet Recalls Pistachios Sold In Michigan Because Of Possible Risk To Health
July 21, 2009
Wirth’s Nutcracker Sweet of Sanford, MI is voluntarily recalling 258 of their 2-lb holiday party trays containing roasted and salted pistachios in the shell because they have 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 may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
Drager Medical Device Recall: Stabilet Contacts Current Users
July 21, 2009
Draeger Medical Inc. recommends the removal of Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 from service and replacing them with alternative warmers as soon as it is feasible.
Luv N Care Recalls all Nuby Gel Filled Teethers and Other Products
July 18, 2009
Luv N’ Care, LTD, Monroe, LA, is initiating a nationwide recall of all Nuby Gel Filled Teethers. These products have been found to contain Bacillus subtilis and Bacillus circulans in the gel. These bacteria generally do not cause illness. However, the bacteria can affect children with weakened immune systems, causing stomach pain, vomiting, and diarrhea, if the teether is punctured and the liquid from the teether is ingested.
Young You Corporation Recalls Weight Loss Pills Found to Contain an Undeclared Drug Ingredient
July 17, 2009
Young You Corporation has been informed by the Food and Drug Administration (FDA) that four weight loss dietary supplements sold and marketed by the firm contain an undeclared drug ingredient. 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. The FDA has not approved the following products as drugs; therefore the safety and effectiveness of this product is unknown.
Teva Pharmaceuticals USA Recalls Propofol Injectable Emulsion
July 17, 2009
Teva Pharmaceuticals and FDA notified healthcare professionals of a recall of Propofol Injectable Emulsion 10 mg/mL 100 mL vials, lot numbers 31305429B and 31305430B. The product lots identified are being recalled due to the presence of elevated endotoxin levels in some vials within these lot numbers. Teva has been notified of 41 propofol-treated patients who experienced post-operative fever, chills and other flu-like symptoms. Adverse health effects, such as fever, chills, or rigors, are possible with exposure to product with elevated levels of endotoxins. Serious adverse effects, such as disseminated intravascular coagulopathy, acute respiratory distress syndrome, shock, and death, are possible with exposure to product with high endotoxin levels.
Kesso Foods Recalls 8 oz. and 16 oz. Low Fat All Natural Plain 2% Greek Thick Yogurt: Salmonella Risk
July 17, 2009
Kesso Foods, Inc. of East Elmhurst, NY is voluntarily recalling 8 oz. and 16 oz. Kesso Foods Lowfat All Natural Plain 2% Greek Thick Yogurt. The affected product has a “SELL BY” date up to and including August 10, 2009. The yogurt is being recalled because it contains nonfat dried milk manufactured by the Plainview Milk Products Cooperative of Plainview, MN. The nonfat dried milk has been subject to an FDA recall due to potential Salmonella contamination. There have been no complaints or reports of illness reported to Kesso Foods, Inc. up to date. The voluntary recall of our product is a precaution to ensure our client safety.
Brookstone Pharmaceuticals Concentrated Acetaminophen Drop Recall
July 17, 2009
NOTE: More info about the Brookstone Pharmaceutical concentrated acetaminophen drops here.
Study Suggests Asthma Medication Xolair Increases Heart Disease Risk
July 16, 2009
Intermin data from a study submitted to the FDA by Genentech, makers of the asthma drug Xolair (omalizumab) “suggests a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events in patients treated with Xolair compared to the control group of patients not given the drug“, according to an FDA statement.
Nature & Health Co. Recalls Six Male Enhancement Products Marketed as Dietary Supplements
July 16, 2009
Opteron 1 Inc. dba Nature & Health Co., announced today that it is conducting a voluntary nationwide recall of the company’s five supplement products sold under the following names: LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule, Herbal Disiac. The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of these five samples found they contains either tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED) , its analog aminotadalafil, or the analog of sidenafil, an active ingredient of another FDA-approved ED drug, making these products unapproved drugs. None of the active drug ingredients are listed on the product labels. The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing.
Brookstone Pharmaceuticals Recalls All Lots of Concentrated Acetaminophen Drops
July 15, 2009
Brookstone Pharmaceuticals, LLC, Alpharetta, GA has initiated a nationwide voluntary recall of all lots of Concentrated Acetaminophen Drops (NDC#42192-504-16) in 16 ounce (473 ml) bulk containers. This 16oz container is comparable to the size generally used to package regular strength acetaminophen liquid preparations. This aspect of the product coupled with the absence of an integrated dosage delivery device is a contributing factor to possible dosing errors, especially inadvertent overdosing. Brookstone has distributed 344 bottles nationally and has donated 5301 bottles to charity for international distribution.
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