U.S. Food & Drug Administration (FDA) ~~ September 2013


English: Logo of the .
English: Logo of the . (Photo credit: Wikipedia)
09/25/2013 10:20 AM EDT
W.S. Badger Co. Inc. today announced it is voluntarily recalling all lots of its 4-ounce SPF 30 Baby Sunscreen Lotion and one lot of its 4-ounce SPF 30 Kids Sunscreen Lotion
09/24/2013 03:17 PM EDT
Garden-Fresh Foods is initiating an expansion to our voluntary recall on various ready-to-eat salads, slaw, and dip products sold under various brands and code dates (see attachment). The products may be contaminated with Listeria monocytogenes, an organism that can cause serious and sometimes-fatal infections in young children, frail or elderly people, and others with weakened immune systems.
09/19/2013 01:39 PM EDT
A limited number of P.F. Chang’s Home Menu Pork and Leek Dumpling frozen appetizer sold at retail in 12.5 ounce bags is being recalled due to the possible presence of undeclared allergens, crustacean shellfish (shrimp) and fish (pollock). There have been no reported cases of illness. This recall does not affect any P.F. Chang’s restaurants.
09/19/2013 07:09 PM EDT
Baxter International Inc. announced today it has initiated a voluntary recall of two lots of its Dual Luer Lock Caps (Product Code 2C6250, Lots 10043 and 10044) because of the presence of loose particulate matter found in the packaging. Particulate matter entering the fluid path from the Luer Lock Caps may result in thrombotic and embolic events, including: pulmonary embolism, myocardial infarction and stroke.
09/20/2013 02:26 PM EDT
Semifreddi’s Inc. of Alameda, CA is recalling all packaged Almond Biscotti and Chocolate Dipped Almond Biscotti because the food allergens milk and soy were not declared on the product labels. People who have an allergy or severe sensitivity to milk or soy run the risk of serious allergic reaction, including anaphylaxis, if they consume the products.
09/16/2013 03:28 PM EDT
HeartSine Technologies, Ltd. initiated a voluntary global correction of certain Samaritan® 300/300P PAD public access defibrillators to address two separate issues that may affect the ability to deliver therapy to a patient in a sudden cardiac arrest (SCA) event, if needed.
09/19/2013 04:25 PM EDT
Wegmans is recalling 4,327 units of Wegmans brand APPLE CINNAMON Mini Muffins, Net Wt. 14 oz., because the product contains undeclared soy. People who have an allergy to soy run the risk of serious or life-threatening allergic reaction if they consume this product.
09/13/2013 07:11 PM EDT
Myerstown, PA – September 12, 2013 – As a result of an internal review, Dutch Valley is issuing a recall on Honey Roasted Peanuts due to undeclared Milk and Wheat Ingredients. Individuals with food allergies to Milk and or Wheat may run the risk of a serious or life threatening allergic reaction if they consume these products.
09/13/2013 06:52 PM EDT
Hospira, Inc. (NYSE: HSP), announced today, on July 12, 2013, it initiated a voluntary nationwide recall to the user level for one lot of 0.25% Bupivacaine HCl Injection, USP (2.5 mg/mL), 30 mL Single-dose Vial (NDC 0409-1159-02). An expanded recall was issued on August 29, 2013 for one lot of 0.75% Bupivacaine HCl Injection, USP (7.5 mg/mL), 30 mL Single-dose Vial (NDC 0409-1165-02).
09/12/2013 05:51 PM EDT
Schwebel Baking Company today recalled 18,979 units of Golden Rich Buns with Honey due to mislabeling and undeclared egg. Through the package validation process the problem was discovered.
09/11/2013 03:44 PM EDT
Leiter’s Compou
09/13/2013 10:56 AM EDT
Ge Pharma, LLC of North Haven, CT is recalling Creafuse Powder Grape Lot# GE4568 and Creafuse Powder Fruit Punch Lot #GE4570, packaged in a white, 600 gram container with an expiration date of 2/2015 because it contains 1,3 dimethylamylamine (DMAA). DMAA is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products.

nding Pharmacy is voluntarily recalling 3 lots of its sterile products due to concerns of sterility assurance with Front Range Laboratories, Leiter’s Compounding Pharmacy’s independent testing laboratory. The use of a non-sterile injectable product exposes patients to the risk of contracting serious life-threatening infections.

09/11/2013 03:52 PM EDT
Talenti® Gelato & Sorbetto is voluntarily initiating a product recall of Talenti German Chocolate Cake Gelato pints with the UPC # 1 8685200063 1 with a BEST BY DATE of 11/04/2014 M1, 11/24/2014 M1, and 11/24/2014 M2 as a precautionary measure. The recall was initiated after it was discovered by the firm that the product may contain undeclared almonds.
09/10/2013 07:23 PM EDT
Bubbles Baking Co. is voluntarily recalling 9,229 cases of Blueberry Muffin 14 oz and Blueberry Loaf Cake 16 oz. due to undeclared milk and soy allergen. People who have allergies to milk and soy run the risk of serious or life-threatening reactions if they consume these products
09/09/2013 03:07 PM EDT
Avella Specialty Pharmacy is voluntarily recalling two compounded sterile medications. The recall is a result of concerns of sterility assurance with the specialty pharmacy‘s independent testing laboratory, Front Range Laboratories.
09/10/2013 01:54 PM EDT
Park Compounding is voluntarily recalling one lot of sterile medication Testoserone Cypionate (Sesame Oil) 200mg/ml Lot #05072013@1 Exp: 11/3/2013 for injection in 10ml amber vials, to the consumer level.
09/09/2013 03:16 PM EDT
General Mills announced today a voluntary Class II recall of a limited quantity of refrigerated Pillsbury Cinnamon Rolls with Icing. No other flavors or varieties of Pillsbury Cinnamon Rolls or Pillsbury dough products are being recalled.
09/06/2013 05:49 PM EDT
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. (“McNeil”) is voluntarily recalling at the retail level three lots, approximately 200,000 bottles, of Concentrated MOTRIN® Infants’ Drops Original Berry Flavor 1/2 fl oz bottles distributed in the United States (see full product list below). This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
09/05/2013 11:51 AM EDT
Chobani, Inc., of Twin Falls, Idaho is voluntarily recalling Greek Yogurt. The company has ceased the distribution of the product due to reports of product bloating and swelling and some claims of illness as the company continues its investigation to identify the root cause.
09/06/2013 05:07 PM EDT
GoPicnic Brands, Inc. is voluntarily recalling two vegan ready-­‐to-­‐ eat meals, GoPicnic Black Bean Dip & Plantain Chips and Hummus & Crackers, containing Professor Zim Zam’s Extraordinary Sweets Dark Chocolate with Orange and Dark Chocolate with Sea Salt. The chocolate products in these meals may contain an undeclared milk allergen.
09/06/2013 07:18 PM EDT
University Compounding Pharmacy is voluntarily recalling the following preparations (see below) for injection, to the consumer level. In a recent inspection, FDA investigators observed that methods used by the Independent Third Party laboratory to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from
09/06/2013 10:01 PM EDT
Aqueboque, NY, Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling a total of nine (9) lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 30 mL, to the consumer level. There have been no reports of adverse effects to consumers so
09/05/2013 03:04 PM EDT
Medaus Pharmacy is voluntarily recalling certain sterile compounded consumer products (see table) due to our inability to confirm that the quality control testing performed on these specific lots by an independent, third party laboratory was conducted in a manner consistent with the highest standards of excellence we demand from ourselves and on behalf of our patients. Though Medaus received test results indicating that these lots met all safety standards, they are being recalled because the independent testing lab’s sterility testing practices as applied to these lots indicate that the product’s sterility cannot be confirmed
09/05/2013 05:01 PM EDT
Cains Foods is recalling 2,273 six-pack cases of 16 oz. Olde Cape Cod Chipotle Ranch dressing with a “Best By” date of Nov. 30, 2014 because it may contain undeclared milk and egg. People who have allergies to milk and egg run the risk of serious or life-threatening reactions if they consume products containing these ingredients.
08/30/2013 06:22 PM EDT
Garden-Fresh Foods, Inc. of Milwaukee Wisconsin is recalling A Limited Quantity of Spartan Fresh Selections American Potato Salad In 16 oz. Packages, because it has 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.
08/30/2013 08:24 PM EDT
Hospira, Inc. announced today it is initiating a voluntary nationwide user-level recall of one lot of Aminosyn II 10 percent, Sulfite-Free, 500mL, NDC 0409-4164-03 Lot 26-138-JT. This action is due to one confirmed customer report where an unknown foreign particle was included in the injection port and in contact with product. The foreign particle was confirmed by Hospira as human hair. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. This recall is being conducted as a precautionary measure.
08/30/2013 08:37 PM EDT
Premier Foods, LLC of Santa Fe Springs, CA is voluntarily recalling four flavored sauces due to the failure to declare the following allergens on the product labels: milk, soy, and/or wheat. The products were sold at Williams-Sonoma. People who have allergies to milk, soy, and/or wheat run the risk of serious or life-threatening reactions if they consume products containing these ingredients.
08/30/2013 04:31 PM EDT
St. Louis, Missouri, Nestle Purina PetCare Company (NPPC) is voluntarily recalling a limited number of 3.5-pound bags of its Purina ONE beyOnd Our White Meat Chicken and Whole Barley Recipe Adult Dry Dog Food from a single production run and shipped to retail customers in the United States. This is being done because one bag of the product was found to be contaminated with Salmonella.

the Senate ~~ CONGRESS 9/25 ~~ the House


matthew 25

Senator Cruz continues to hold the floor to debate H.J.Res.59, the Continuing Resolution.

If the debate continues until noon the Chair would interrupt debate to begin the new Legislative Day and to allow the Chaplain to deliver the prayer. There would then be up to 1 hour for debate prior to the cloture vote on the motion to proceed to the Continuing Resolution.

Senators should expect a roll call vote at 1:00pm on the motion to invoke cloture on the motion to proceed to H.J.Res.59, the Continuing Resolution. If cloture is invoked, there would be up to 30 hours for debate prior to a vote on adoption of the motion to proceed.

The Senate has begun a new session day (new calendar day, not legislative day). There will now be up to 1 hour for debate prior to a cloture vote on the motion to proceed to H.J.Res.59, the Continuing Resolution. At 1pm the Senate will proceed to a cloture vote on the motion to proceed to H.J.Res.59, the Continuing Resolution.

Senator Cruz asked unanimous consent to vitiate the 1pm cloture vote and at the end of his remarks the Senate agree to the motion to proceed to H.J.Res.59, the Continuing Resolution.

Senator Reid objected.

Senator Cruz then asked consent that if a cloture motion is filed on H.J.Res.59, the Continuing Resolution, that the cloture vote occur Friday afternoon.

Senator Reid objected.

12:55pm The Senate began a 15 minute roll call vote on the motion to invoke cloture on the motion to proceed to H.J.Res.59, Continuing Resolution;

Invoked: 100-0

By unanimous consent, the Senate passed H.R.3092, the Missing Children’s Assistance Reauthorization Act of 2013.

The Senate adopted the motion to proceed to H.J.Res.59, the Continuing Resolution, by a voice vote. Senator Reid then offered a perfecting substitute amendment #1974 and a second degree amendment #1975 (date change). Senator Reid also moved to recommit the joint resolution and offered amendments to the motion in the first and second degree slots (#1976 and 1977 (date changes)). He then filed cloture on the joint resolution.

If no agreement is reached under Rule 22, the cloture vote on the Continuing Resolution would occur 1 hour after the Senate convenes on Friday. The filing deadline for germane first degree amendments to H.J.Res.59, is 1:00pm tomorrow.

WRAP UP

ROLL CALL VOTE

1)      Motion to invoke cloture on the motion to proceed to H.J.Res.59, Continuing Resolution: Invoked: 100-0

LEGISLATIVE ITEMS

Passed H.R.3092, the Missing Children’s Assistance Reauthorization Act of 2013

Passed Cal. # 13, 252, PREEMIE Act, by voice vote

Passed S.793, Organization of the American States Reform

The Senate adopted the following resolutions by unanimous consent:

S.Res.255, a resolution welcoming the Prime Minister of India to the United States for meetings to advance the United States-India partnership

S.Res.256, designating the week of September 23, through 29, 2013, as “National Adult Education and Family Literacy Week”

S.Res.257, Designating October 3, 2013, as “Jumpstart’s Read for the Record Day”

S.Res.258, supporting the goals and ideals of Infant Mortality Awareness Month, 2013

S.Res.259, Designating September 2013 as “Campus Fire Safety Month”

S.Res.260, Recognizing the month of October 2013 as “National Principals Month”

*****************************************************************

Last Floor Action: 9/23
11:03:25 A.M. – The Speaker announced that the House do now adjourn pursuant to a previous special order.

The next meeting is scheduled for 12:00 p.m. on September 25, 2013.

Last Floor Action:
2:11:41 P.M. – The Speaker announced that the House do now recess.

The next meeting is scheduled for approximately 5:00 P.M. today.

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Causes.com


We bring the Amazon to you on Wednesday

Mayalu Txucarramãe

Join us this Wednesday in San Francisco for our 8th Annual Luncheon or watch it live online at Causes.com.

Our special guest, Mayalú Txucarramãe, Kayapó and Waura youth leader, representing indigenous partners working to stop dams in the Brazilian Amazon, will give us her perspective and share her experience of living this struggle for as long as she can remember. Granddaughter of legendary Chief Raoni, daughter of Chief Megaron, Mayalú brings the story of fighting for the people and region of the Xingu to life.

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For the Amazon,

Paul Paz y Miño
Paul Paz y Miño
Online & Operations Director

The Affordable Care Act & small business


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When it comes to the Affordable Care Act, our nation’s leaders maintain a dialogue with the country’s businesses, large and small. The work is ongoing, but the Administration has responded to your concerns by making changes to simplify the reporting process and giving businesses more time to comply.

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$#!^@#%!


GOP Takes Obamacare Meltdown To A Whole New Level

A mere seven days remain for Congress to pass a spending bill in order to avoid a government shutdown. But Republicans are farther away than ever from agreeing to a reasonable plan that would keep the government open.

On Friday, the House GOP continued its march toward shutdown by passing a bill that ties keeping the government open to–surprise!–fully defunding Obamacare. Once again, Republicans refuse to do the hard work of actual governing in favor of playing political games that threaten to sabotage the economy. But while the vote only solidified the GOP’s ideological and dangerous strategy, it opened the floodgates for more infighting among its owns members. Here is what a number of key GOP players and establishment thinkers have to say about the “defund at all costs” plan:

  • GOP Sen. John McCain (AZ): “I can tell you that in the U.S. Senate, we will not repeal or defund Obamacare. We will not. And to think we can is not rational.”
  • GOP Strategist Karl Rove: The GOP defunding strategy is “self-defeating…It is an ill-conceived tactic, and Republicans should reject it.”
  • Fox News Host Bill O’Reilly: Defunding Obamacare is “fanaticism on the right,” O’Reilly says. “There’s no way Obamacare is going to be defunded. It’s not gonna happen.”
  • GOP Sen. Tom Coburn (OK): “Tactics and strategies ought to be based on what the real world is, and we do not have the political power to do this.”
  • GOP Sen. Rand Paul (KY): “I’m acknowledging we can’t probably defeat or get rid of Obamacare.”
  • GOP Sen. Kelly Ayotte (NH): “I don’t believe they should shut down the government to [defund Obamacare], and I don’t think that is a strategy that is good for America.”
  • GOP Sen. Johnny Isakson (GA): “It’s total atrophy. We’re earning our 11 percent popularity. It’s easier to talk about Obamacare than the major sources of our problems.”
  • Wall Street Journal Editorial Board: “Kamikaze missions rarely turn out well, least of all for the pilots… The kamikazes could end up ensuring the return of all-Democratic rule.”

Now, they all may just be trying to protect their party’s interests. But they seem to know what most Americans already do: the extreme demands by the GOP to push a narrow ideological agenda are out of touch. A new bipartisan CNBC poll released today proves that point. Almost six in ten Americans oppose defunding the health care law if it means a government shutdown, while just 19 percent support. A poll released last week found that only 23 percent of Americans want to make the health care law fail.

BOTTOM LINE: Republicans’ political games are threatening our nation’s economic recovery. Americans don’t want to shut down the government and want an end to the hostage-taking political tactics that place ideology over practical solutions for stability and growth.

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