U.S. Food & Drug Administration (FDA)


 

English: Logo of the U.S. Food and Drug Admini...

English: Logo of the U.S. Food and Drug Administration (2006) (Photo credit: Wikipedia)

Symbios Medical Products Issues Nationwide Recall of GOPump and GOBlock Kits

05/16/2013 03:49 PM EDT
May 10, 2013 – Symbios Medical Products initiated a voluntary recall of all GoPump Rapid Recovery System kits and GOBlock Kits manufactured with flow control components assembled prior to July 2012. These products have been found to potentially cause excessively high flow rates, which presents a risk of patient toxicity and serious injury (e.g., seizure, dysrhythmia, death) due to the rapid influx of medication particularly in patients with low body mass or advanced age.
 
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05/17/2013 01:19 PM EDT
Pentec Health, Inc. has decided to initiate a limited, voluntary recall of in-date nutritional prescriptions for renal patients due to lack of sterility assurance associated with one of its laminar flow hoods used in compounding. The recall covers renal therapies that were compounded in this hood on or before May 2, 2013.
 
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Tropical Valley Foods Issues

Allergy Alert on Undeclared Milk and Walnuts in Next by Nature Dark Chocolate Bananas

05/17/2013 11:54 AM EDT
Tropical Valley Foods Inc. of Plattsburgh, NY, is recalling next by Nature DARK CHOCOLATE BANANAS, 3 oz. bags, due to undeclared milk and walnuts. People who have an allergy to milk and/or walnuts run the risk of serious or life-threatening allergic reaction if they consume this product.
 
 
 

U.S. Food & Drug Administration (FDA)


English: Logo of the .

English: Logo of the . (Photo credit: Wikipedia)

 
05/10/2013 09:37 AM EDT
Krinos Foods, LLC. of Long Island City, New York is voluntarily recalling its TAHINI sesame paste, 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 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.
 
05/10/2013 08:53 AM EDT
Dairy Fresh is voluntarily recalling a specific batch of IGA Brand “Vanilla & Chocolate” Ice Cream (1.75 quart, 1.66L) with the plant code “3783” and a SELL BY date of 08-13-13 because it incorrectly contains Heavenly Hash ice cream, which contains almonds, coconut, and soy, which are allergens not declared on the carton. People who have an allergy or severe sensitivity to almonds, coconut, or soy run the risk of serious or life-threatening allergic reaction if they consume this product.
 
05/09/2013 05:28 PM EDT
Bimeda Inc., on behalf of the manufacturer, Bimeda-MTC Animal Health Inc. is voluntarily recalling one lot of Calcium Gluconate, one lot of Dextrose 50%, and one lot of Hypertonic Saline, all of which are in the form of injectable fluids, to the user level. These injectable fluids are being recalled as a precautionary measure; because of departures from customary sterility procedures, sterility cannot be entirely assured.
 
 
05/09/2013 05:35 PM EDT
Today, Pure Herbs Ltd., Sterling Heights, MI is voluntarily recalling the 4oz and 1oz bottles of Protein Extract because they contain undeclared allergens – milk and soy. This labeling error was discovered during a routine Food and Drug Administration (FDA) inspection when a review of the ingredients found that milk and soy allergen ingredients were not listed on our main label.
 
 
05/09/2013 07:36 PM EDT
May 9, 2013 – CAMBRIDGE, MA. – Whole Foods Market is recalling bulk curried chicken salad and bulk vegan curried chick’n salad because in some stores these items may have been sold with reversed labels causing undeclared soy and egg allergens. Due to the label mix-up, allergens were undeclared; the vegan chick’n salad contains soy, and the curried chicken salad contains egg.
 
 
 
05/08/2013 05:19 PM EDT
Nutraceutical company XYMOGEN in Orlando, Fla., is recalling artriphen, a product recommended for the support of healthy joint function, because it contains traces of the undeclared allergens soy and milk.

U.S. Food & Drug Administration (FDA)


 
   English: Logo of the .
04/29/2013 04:13 PM EDT
WESTON, FL, April 26, 2013 /CNW/ – Apotex Corp. announced today that it is conducting, on behalf of the manufacturer Hospira, Inc., a voluntary nationwide recall of 15 lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams, NDC number 60505-0773-00 to the hospital / healthcare provider /user level. The impacted lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams may show precipitation / crystallization in IV bag or IV line after reconstitution.
 
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04/29/2013 03:46 PM EDT
Smart & Final of Los Angeles, Calif. is recalling 2.5 lb. La Romanella Tri-Color Cheese Tortellini because it may contain undeclared wheat, eggs and milk. People who have an allergy or severe sensitivity to wheat, eggs and /or milk run the risk of serious or life-threatening allergic reaction if they consume these products.
 
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04/29/2013 02:26 PM EDT
Maple View Farm is voluntarily recalling pint containers of Cookies & Cream, Carolina Crunch and Cookie Dough ice cream because the products contain allergens that were not declared on package labels. Some or all of the products contain wheat,soy, almonds and peanuts, which can cause serious allergic reactions in people who have an allergy or sensitivity to these ingredients.
 
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04/27/2013 03:07 PM EDT
Today, ConAgra Foods, Inc., (NYSE: CAG) in cooperation with the U.S. Food and Drug Administration (FDA) is voluntarily recalling packages of its Orville Redenbacher’s Classic Kettle Korn flavor ready-to-eat popcorn that may contain an undeclared allergen, milk. Certain bags of the Kettle Korn flavored ready-to-eat popcorn may have inadvertently been filled with white cheddar flavored popcorn, which contains an allergen, milk.
 
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04/26/2013 08:22 AM EDT
Hospira, Inc. (NYSE: HSP), announced today that last August it initiated a voluntary nationwide user-level recall of one lot of 0.9% Sodium Chloride Injection, USP, 100 mL, Flexible Container, NDC 0409-7984-23. This action was due to one confirmed customer report where four separate particulate issues were identified in four individual flexible containers.

U.S. Food & Drug Administration (FDA)


Fda

Fda (Photo credit: Wikipedia)

 

04/26/2013 11:22 AM EDT
April 23, 2013 – Saratoga Therapeutics, LLC of North Wales, PA is recalling 900 bottles of ebA Multivitamin Supplement because they may contain undeclared milk components –milk protein(s) and lactose. The following lot numbers may be affected: # 0912164 expiration date 12/12 # 1110354 expiration date 10/14 People with an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction and people who have lactose intolerance run the risk of gastrointestinal symptoms if they consume ebA Multivitamin Supplement.
 
04/26/2013 08:22 AM EDT
Hospira, Inc. (NYSE: HSP), announced today that last August it initiated a voluntary nationwide user-level recall of one lot of 0.9% Sodium Chloride Injection, USP, 100 mL, Flexible Container, NDC 0409-7984-23. This action was due to one confirmed customer report where four separate particulate issues were identified in four individual flexible containers.
 
 
 
04/25/2013 11:00 AM EDT
Based on its investigation into a small number of complaints that the delivery system of the device had separated at the tip of the inner catheter, Cook Medical has initiated a nationwide/global voluntary recall of its Zilver® PTX® Drug Eluting Peripheral Stent. Cook received 13 complaints of delivery system tip separation with an occurrence rate of 0.043 percent.
 
 

7th Heaven Bakeries Issues Allergy Alert on Undeclared Egg, Soy And Milk in Oatmeal Raisin Cookies

04/24/2013 12:52 PM EDT
7th Heaven Bakeries, Oklahoma City, is recalling OATMEAL RAISIN COOKIES, because they may contain undeclared dry eggs, soy lecithin, and whey solids. People who have an allergy or severe sensitivity to eggs, soy and milk run the risk of serious or life-threatening allergic reaction if they consume these products.
 
 
 
 
 

U.S. Food & Drug Administration (FDA)


English: Logo of the .

English: Logo of the . (Photo credit: Wikipedia)

04/23/2013 10:44 AM EDT
Nora Apothecary & Alternative Therapies today announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013.
 
04/23/2013 10:47 AM EDT
On January 8, 2013, GE Healthcare initiated a nationwide voluntary field corrective action of the Giraffe Incubator with a Servo Control Oxygen System and Giraffe OmniBed, which were manufactured from August 1, 2012 through December 20, 2012. Giraffe Incubators without a Servo Control Oxygen System are not impacted.

Natura Pet Expands Voluntary Recall of Dry Pet Foods Due to Possible Health Risk.

Natura Pet Products is voluntarily expanding its March 29, 2013 recall of dry pet foods because they have the potential to be contaminated with Salmonella

04/22/2013 04:04 PM EDT
April 22, 2013 – Go Max Go Foods LLC, announces that it has taken the precautionary measure of voluntarily withdrawing a limited quantity of vegan candy bar products. These products contain the following statement on the front label: “dairy-free”, which may lead to confusion for people who have allergies to milk products
 
 

U.S. Food & Drug Administration (FDA)


04/17/2013 10:44 PM EDT
Prime Food USA, 50st & 1st Ave Building # 57, Brooklyn NY 11232, is recalling Latis Brand Herring Fillet “Matiej”, Salmon Fillet Slices and Herring Fillet “Forelka” in Oil due to contamination with listeria monocytogenes.
 
 
04/17/2013 12:34 PM EDT
Abbott today announced it is initiating a voluntary recall of FreeStyle lnsulinx® Blood Glucose Meters in the United States. The company has determined that at extremely high blood glucose levels of 1024 mg/dL and above, the FreeStyle lnsulinx Meter will display and store in memory an incorrect test result that is 1024 mg/dL below the measured result.
 
 
04/16/2013 09:52 PM EDT
Wegmans Food Markets is recalling approximately 1,100 affected units of Wegmans Food You Feel Good About Roasted Red Pepper Dip, 8 oz. tub, with a best-by date of 5/17/13, because some of the tubs may have an incorrect ingredient label that does not list milk and eggs. People who have an allergy or severe sensitivity to milk or eggs run the risk of serious or life-threatening allergic reaction if they consume these products.
 
 
04/16/2013 02:51 PM EDT
April 15, 2013 – Cedarlane Natural Foods, Inc., is voluntarily recalling one specific lot of O Organics Black Bean Enchiladas because they contain undeclared milk. People with an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reactions if they consume this product
 
 
04/15/2013 12:51 PM EDT
Winn-Dixie today announced an immediate voluntary recall of 64 FL OZ Winn-Dixie Organic 100% Apple Juice. The product is being recalled as a precaution because it could have levels of “patulin” that exceeds FDA limits.

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.

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.

U.S. Food & Drug Administration (FDA).


03/06/2013 08:12 PM EST
Tri-Union Seafoods LLC is voluntarily recalling a limited amount of Chicken of the Sea brand 5-ounce cans of chunk white albacore tuna in water. The seams on the lids of the cans do not meet the standard for seam quality.
03/06/2013 01:23 PM EST
Bumble Bee Foods, LLC, has issued a voluntary recall on specific codes of 5-ounce Chunk White Albacore and Chunk Light Tuna products. The recall has been issued because the products do not meet the companies standards for seal tightness.
03/05/2013 12:36 PM EST
The Kroger Co. (NYSE: KR) Bakery in Clackamas, Oregon is recalling select Wheat Bread products sold at the company’s Fred Meyer Stores in Idaho, Oregon and Washington and QFC stores in Oregon and Washington because these products may contain pieces of plastic. Customers should return the product to stores for a full refund or replacement.
03/05/2013 07:13 PM EST
Cargill’s animal nutrition business today announced a voluntary recall of certain brands of its ruminant mineral products because they were deficient in vitamins A, D and E. The affected products were manufactured at Cargill’s facilities in McPherson, Kansas, and Montgomery City, Missouri, between Dec. 7, 2012, and Feb. 27, 2013.

CONGRESS: the Republican led House / the Senate considers S.1940,Flood Ins ,S.2343,Student Loan & Transportation bills


the Senate Convenes: 9:30amET June 27, 2012

  • Following the prayer and pledge, the Majority Leader will be recognized.  The Senate will continue to debate S.1940, the Flood Insurance bill on Wednesday’s session.
  • The first hour will be equally divided and controlled between the two Leaders or their designees with the Majority controlling the first half and the Republicans controlling the final half.
  • We hope to reach an agreement to complete action on the flood insurance bill.  We will also consider the transportation bill and the student loan extension prior to the recess.

WRAP UP

No ROLL CALL VOTES

LEGISLATIVE ITEMS

Adopted S.Res.511, commending the Pacific Lutheran University Lutes Softball Team for winning the 2012 National Collegiate Athletic Association Division III Softball Championship.

Adopted S.Res.512, recognizing the 100th anniversary of Rice University.

Began the Rule 14 process of S.3342, a bill to improve information security and for other purposes. (McCain and others)

No EXECUTIVE ITEMS

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http://clerk.house.gov/floorsummary/floor.aspx