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~ FDA/USDA ~~ Alerts & Safety

U.S. Food & Drug Administration (FDA) – June 2013

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06/28/2013 02:25 PM EDT
June 26, 2013 – MINNEAPOLIS – In June 2013, Medtronic, Inc. (NYSE: MDT) initiated four medical device notifications to customers worldwide about the SynchroMed Implantable Infusion System. These notifications provide clinicians with information to help identify and manage issues that impact the safe and reliable delivery of therapy using the SynchroMed Implantable Infusion System.
06/28/2013 01:15 PM EDT
Miami, Florida Dolphin Intertrade Corp. is voluntary recalling “JaDera” and “Xiyouji Qingzhi” Weight Loss Supplement. These product have been found to contain undeclared Sibutramine, Sibutramine was a previously approved controlled substance for the treatment of obesity that was removed from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.
06/26/2013 09:22 PM EDT
Scenic Fruit Company of Gresham, Oregon today announced it is voluntarily recalling 5,091 cases (61,092 eight ounce bags) of Woodstock Frozen Organic Pomegranate Kernels. Based on an ongoing epidemiological and traceback investigation by the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) of an illness outbreak, the kernels have the potential to be contaminated with Hepatitis A virus.
06/25/2013 09:02 PM EDT
Schenectady, NY: Price Chopper Supermarket is voluntarily recalling three varieties of Burst Cookies- Brownie, Almond and Raspberry- a frozen cookie produced by Jacqueline’s Wholesale Bakery and baked off in all of the chain’s in-store bakeries, due to the presence of milk, a known allergen, which was not declared on the ingredient label. The product is not harmful in any way to those who are not allergic to milk products.
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06/22/2013 02:24 PM EDT Beta Labs, LTD (“Beta”), dietary supplement retailer, is recalling Oxyphen XR
Lot #s 200910 and 200911, Phentalene Lot # 58800512, Phen FX Lot # 1205129, and Red Vipers Lot # 1205128 (hereinafter referred to as the “Products”). The recall was initiated on June 15, 2013, after a review of recent FDA communications related to 1,3 dimethylamylamine (“DMAA”). The Products contain DMAA.
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06/21/2013 01:58 PM EDT
Taylor Farms New Jersey, Inc. of Swedesboro, NJ is voluntarily recalling a limited quantity of Black Forest Ham and Cheese on a Pretzel Roll with Swiss Cheese and Country Dijon Honey Mustard because they have the potential of containing an undeclared tree nut allergen. People who have severe sensitivity or allergies to tree nuts may run the risk of a serious or life threatening allergic reaction if they consume these products.
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06/19/2013 05:27 PM EDT
Holtsville, NY, Advance Pharmaceutical Inc. today announced that this firm is conducting a voluntary nationwide recall to the user level of the over-the-counter drug product, Rugby label Enteric Coated Aspirin Tablets, 81 mg, Lot 13A026. Advance Pharmaceutical Inc. first initiated the recall on June 17, 2013, after receiving a complaint about a bottle labeled as Enteric Coated Aspirin Tablets, 81 mg, actually containing Acetaminophen 500 mg tablets
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06/19/2013 05:24 PM EDT
Garden-Fresh Foods Inc. is voluntarily recalling a limited number of packages of Archer Farms Smoked Salmon Dip that may contain undeclared allergens, fish and egg. Some of Archer Farms Smoked Salmon Dip may have inadvertently been filled in a limited amount of Bacon Parmesan Dip containers.
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06/18/2013 06:54 PM EDT
OSKRI Corp. of Lake Mills, WI is recalling “Coconut Bar Dark Chocolate”, “Coconut Bar Dark Chocolate Minis”, “Fig Dark Chocolate Bars” and “Almond Dark Chocolate Bars” because the dark chocolate contains milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
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06/18/2013 01:58 PM EDT
Natura Pet Products is voluntarily recalling specific lots of dry pet food because it has the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
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06/14/2013 09:16 PM EDT
See’s Company of San Francisco is recalling all Milk and Dark Raisins because it may contain undeclared tree nuts and eggs. People who have an allergy or severe sensitivity to tree nuts (e.g.: almonds, walnuts, pecans, cashews) and/or eggs run the risk of serious or life-threatening allergic reaction if they consume these products
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06/14/2013 08:13 PM EDT
OSKRI Corp. of Lake Mills, WI is recalling “Coconut Bar Dark Chocolate”, “Coconut Bar Dark Chocolate Minis”, “Fig Dark Chocolate Bars” and “Almond Dark Chocolate Bars” because the dark chocolate contains milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
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06/14/2013 09:57 AM EDT
Lipari Foods of Warren, MI is recalling Raw Sunflower Seeds, Roasted Sunflower Seeds and Snack Mixes, because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
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06/13/2013 09:04 PM EDT
Sequel Naturals Ltd. Dba “Vega” is voluntarily recalling a limited quantity of nutrition bars due to finding trace amounts of milk in some lot codes
~ FDA/USDA ~~ Alerts & Safety

U.S. Food & Drug Administration (FDA)

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English: Logo of the U.S. Food and Drug Admini...
English: Logo of the U.S. Food and Drug Administration (2006) (Photo credit: Wikipedia)
06/13/2013 12:30 PM EDT
Sagent Pharmaceuticals, Inc. today announced the expanded voluntary nationwide recall of Vecuronium Bromide for Injection 10mg (NDC number 25021-657-10) manufactured by Mustafa Nevzat Ilac Sanayii A.S. (MN Pharmaceuticals) and distributed by Sagent. Sagent initiated a voluntary recall of Vecuronium Bromide for Injection to the user level for three lots on June 7, 2013 due to the discovery of an elevated impurity result detected during routine quality testing of stability samples at the 18-month interval.
06/13/2013 02:08 PM EDT
June 12, 2013 – St. Augustine, FL (PRWEB) – Butterfly Bakery issues allergy alert on undeclared Walnuts in 14.5 ounce Butterfly Bakery Whole Grain Harvest Berry Muffins, UPC 6 43482 60014 8. People who have an allergy or severe sensitivity to Walnuts (a type of tree nut) run the risk of serious or lifethreatening allergic reaction if they consume these products. This product has not been produced since November 26, 2012.
06/12/2013 04:41 PM EDT
Zydus Pharmaceuticals USA Inc. is voluntarily recalling one lot of Warfarin 2 mg Tablets, Lot # MM5767, expiration date June 2014 to the retail level. Four tablets of Warfarin 2 mg Tablets, Lot MM5767, have been found to be oversized in one product complaint.
06/13/2013 11:31 AM EDT
SECAUCUS, N.J., /PRNewswire/ – The Hartz Mountain Corporation, located in Secaucus, N.J. is voluntarily recalling one specific lot of Wardley Betta Fish Food 1.2 oz. size due to concerns that one or more containers within the lot may have been potentially contaminated with Salmonella. Hartz is fully cooperating with the US Food and Drug Administration in this voluntary recall.
06/11/2013 02:22 PM EDT
Bethel Nutritional Consulting, Inc. was informed by the Food and Drug Administration (FDA) that a sample of Bethel 30 green capsule was collected and tested by FDA in April 24, 2013. The capsules tested positive for Sibutramine and Phenolphthalein.
06/12/2013 02:46 PM EDT
Julian’s Recipe, LLC., in cooperation with the U.S. Food and Drug Administration (FDA), is voluntarily withdrawing its European Style Pretzel Baguette packages from HEB Stores in Texas. Certain packages of Pretzel Baguettes may contain Julian’s European Style Multigrain Garlic Baguettes, which are made with soy flour.
06/10/2013 02:54 PM EDT
SCHAUMBURG, IL – Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of three lots of Vecuronium Bromide for Injection 10mg (NDC number 25021-657-10) manufactured by Mustafa Nevzat Ilac Sanayii A.S. (MN Pharmaceuticals) and distributed by Sagent. Sagent has initiated this voluntary recall of Vecuronium Bromide for Injection to the user level due to the discovery of an elevated impurity result detected during routine quality testing of stability samples at the 18-month interval.
06/10/2013 10:01 AM EDT
Alderman Farms Sales Corporation, Boynton Beach, Florida is recalling one pint containers of Certified Organic Cherry Tomatoes 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, nausea, vomiting and abdominal pain.
06/04/2013 11:21 AM EDT
Townsend Farms, Inc. of Fairview, Oregon, today announced that it is voluntarily recalling certain lots of its frozen Organic Antioxidant Blend, out of an abundance of caution, because it has the potential to be contaminated with Hepatitis A virus, based on an ongoing epidemiological and traceback investigation by the FDA and the CDC of an illness outbreak. No other Townsend Farms products, frozen or fresh, are covered by this voluntary recall or linked to the illness outbreak at this time.
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U.S. Food & Drug Administration (FDA)


04/12/2013 01:34 PM EDT
April 12, 2013 – Wild Blue Yonder Foods of Lynn, MA is voluntarily recalling 834 cases of Chappaqua Crunch GF (Gluten Free) Simply Granola with Flax & Fruit because they contain undeclared almonds. People who have an allergy or severe sensitivity to almonds and other tree nuts run the risk of serious or life-threatening allergic reaction if they consume this product.
04/10/2013 09:41 PM EDT
Henderson, NV, Green Valley Drugs is voluntarily recalling All Lots of All Sterile products compounded, repackaged, and distributed by the pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. A full list of the recalled products is attached to this press release and can be accessed at greenvalleymed.com.
04/10/2013 08:08 PM EDT
Affirm XL, Inc. is conducting a voluntary recall to the consumer level after FDA lab analysis testing found the product to contain an analogue of sildenafil. Sildenafil is an active ingredient used in an FDA-approved product for the treatment of male Erectile Dysfunction (ED).
04/10/2013 04:41 PM EDT
Stryker Corporation (NYSE:SYK)announced today that its orthopaedic division has received notice that the U.S. Food and Drug Administration (FDA) has reviewed the voluntary recall of its ShapeMatch Cutting Guides and that it will be classified as a Class I recall. ShapeMatch Cutting Guides are intended to be used as patient specific surgical instrumentation to assist in the positioning of total knee replacement components intraoperatively and in guiding the marking of bone before cutting.
~ FDA/USDA ~~ Alerts & Safety, ~ politics petitions pollution and pop culture

U.S. Food & Drug Administration (FDA)


04/08/2013 02:18 PM EDT
Consumer Concepts, Inc. is conducting a consumer/user level recall of all ROCK-It MAN Male Enhancement Capsules sold between October, 2012 and April, 2013. Finished product of ROCK-It MAN Male Enhancement Capsules was tested and found to contain an analogue of an ingredient in an FDA-approved drug.
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Relocating endangered deer


deer

http://bcove.me/2uuwr3po

click on link above for the video

 

Crews have been working to relocate the endangered Columbian white-tailed deer from the Julia Butler Reserve. A dike built in the 1920s is eroding and the area may soon flood daily.