FDA Alerts Consumers of Nationwide Voluntary Recall of EpiPen and EpiPen Jr

 

SILVER SPRING, MD – The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies’ voluntary recalldisclaimer icon of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency treatment of severe allergic reactions. This recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty.

While the number of reported failures is small, EpiPen products that potentially contain a defective part are being recalled because of the potential for life-threatening risk if a severe allergic reaction goes untreated. Consumers should keep and use their current EpiPens if needed until they get a replacement. Consumers should contact Mylan at 800-796-9526 or customer.service@mylan.com with any questions.

As stated on the product label, consumers should always seek emergency medical help right away after using their EpiPens, particularly if the device did not activate.

At this time, the 13 lots identified – distributed between Dec. 17, 2015, and July 1, 2016 – are the only EpiPen lots impacted by the U.S. recall. Consumers who have EpiPens from lots that are not included in this recall, do not need to replace their EpiPen prior to its expiration date.

Product/Dosage NDC Number Lot Number Expiration Date
EpiPen Jr Auto-Injector, 0.15 mg 49502-501-02 5GN767 April 2017
EpiPen Jr Auto-Injector, 0.15 mg 49502-501-02 5GN773 April 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 5GM631 April 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 5GM640 April 2017
EpiPen Jr Auto-Injector, 0.15 mg 49502-501-02 6GN215 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM082 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM072 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM081 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM088 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM199 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM091 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM198 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM087 October 2017

 

The FDA asks health care professionals and consumers to report any adverse reactions or device malfunctions to the FDA’s MedWatch program, by:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA Approves New Drug to Treat Multiple Sclerosis

 

SILVER SPRING, MD – On March 28, the U.S. Food and Drug Administration approved Ocrevus (ocrelizumab) to treat adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). This is the first drug approved by the FDA for PPMS. Ocrevus is an intravenous infusion given by a health care professional.

“Multiple sclerosis can have a profound impact on a person’s life,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “This therapy not only provides another treatment option for those with relapsing MS, but for the first time provides an approved therapy for those with primary progressive MS.”

MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs more frequently in women than men. For most people with MS, episodes of worsening function (relapses) are initially followed by recovery periods (remissions). Over time, recovery may be incomplete, leading to progressive decline in function and increased disability. Most people experience their first symptoms of MS between the ages of 20 and 40.

PPMS is characterized by steadily worsening function from the onset of symptoms, often without early relapses or remissions. The U.S. Centers for Disease Control and Prevention estimates that approximately 15 percent of patients with MS have PPMS.

The efficacy of Ocrevus for the treatment of relapsing forms of MS was shown in two clinical trials in 1,656 participants treated for 96 weeks. Both studies compared Ocrevus to another MS drug, Rebif (interferon beta-1a). In both studies, the patients receiving Ocrevus had reduced relapse rates and reduced worsening of disability compared to Rebif.

In a study of PPMS in 732 participants treated for at least 120 weeks, those receiving Ocrevus showed a longer time to the worsening of disability compared to placebo.

Ocrevus should not be used in patients with hepatitis B infection or a history of life-threatening infusion-related reactions to Ocrevus. Ocrevus must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. Ocrevus can cause infusion-related reactions, which can be serious. These reactions include, but are not limited to, itchy skin, rash, hives, skin redness, flushing, low blood pressure, fever, tiredness, dizziness, headache, throat irritation, shortness of breath, swelling of the throat, nausea, and fast heartbeat. Additionally, Ocrevus may increase the risk for malignancies, particularly breast cancer. Delay Ocrevus treatment for patients with active infections. Vaccination with live or live attenuated vaccines is not recommended in patients receiving Ocrevus.

In addition to the infusion-related reactions, the most common side effect of Ocrevus seen in the clinical trials for relapsing forms of MS was upper respiratory tract infection. The most common side effects in the study of PPMS were upper respiratory tract infection, skin infection, and lower respiratory tract infection.

The FDA granted this application breakthrough therapy designation, fast track designation, and priority review.

The FDA granted approval of Ocrevus to Genentech, Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The Agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Indian Affairs Committee Approves Bill to Protect Tribal Veterans’ Health Care

 

Photo: IHS

March 29, 2017

WASHINGTON — U.S. Sens. John Thune (R-S.D.) and Mike Rounds (R-S.D.), a member of the Senate Veterans’ Affairs Committee, applauded the Senate Committee on Indian Affairs for passing the Tribal Veterans Health Care Enhancement Act (S. 304), legislation they reintroduced in February that would improve tribal veterans’ access to health care. The committee approved the bill, which now heads to the full Senate for its consideration, by voice vote.

The bill, which was first introduced in the 114th Congress, would allow the Indian Health Service (IHS) to cover copay costs for tribal veterans who are referred by IHS to the Veterans Health Administration (VA) for services that are unavailable at IHS facilities. These referrals often require a copay that is currently the responsibility of the veteran. The bill would also require the IHS and VA, in consultation with Indian tribes, to outline an implementation plan through a memorandum of understanding.

“It’s unfortunate that tribal veterans, who fought bravely for our country, are too frequently caught between the bureaucracies of the IHS and VA,” said Thune. “The Tribal Veterans Health Care Enhancement Act is a common-sense fix that would require these agencies to work more effectively so they can deliver the quality care tribal veterans deserve. Our bill has strong bipartisan support, as evidenced by today’s vote in the Indian Affairs Committee, and I hope my colleagues in the Senate are able to consider it as soon as possible.”

“Tribal veterans shouldn’t have to worry about additional costs when they seek health care services,” said Rounds. “The priority is that they receive quality care in a timely manner. Our legislation will help streamline health care for all Native American veterans to make certain they receive the care they’ve been promised. I’m pleased to see our commonsense legislation taking this important step forward today.”

The Tribal Veterans Health Care Enhancement Act would:

·         Allow for IHS to pay for veterans’ copayments for services rendered at a VA facility, pursuant to an IHS referral;

·         Require IHS and VA to enter into a memorandum of understanding to provide for such payment; and

·         Require a report within 90 days of enactment with respect to:

o   The number, by state, of eligible Native American veterans utilizing VA medical facilities;

o   The number of referrals, by state, received annually from IHS to the VA from 2011 to 2016; and

o   Update on efforts at IHS and VA to streamline care for eligible Native American veterans who receive care at both IHS and VA, including changes required under the Indian Health Care Improvement Act and any barriers to achieve efficiencies.

Supreme Court Justices In The Pews and On The Bench – Where Neil Gorsuch Fits In

 

Supreme Court nominee, Neil Gorsuch. Joshua Roberts

 

Steven K. Green,
Willamette University

On Jan. 31, President Donald Trump nominated Judge Neil M. Gorsuch of the Tenth Circuit Court of Appeals to fill the vacancy on the Supreme Court occasioned by the death of Justice Antonin Scalia. The Senate hearing on Judge Gorsuch’s nomination to the Supreme Court started on Monday, March 20.

As important as is a Supreme Court confirmation, Congress and the media have focused chiefly on the numerous controversies that have embroiled the new Trump administration. One media outlet even called Gorsuch’s confirmation process the “stealth Supreme Court nomination.”

Judge Gorsuch has a reputation as a judicial conservative in the mold of Scalia. He has not ruled on several controversial issues such as gun rights, but the conventional wisdom among court watchers is that if confirmed, the “young” (49-year-old) Gorsuch will swing the high court back to the right on many social issues and will impact Supreme Court jurisprudence for decades to come. As a result, progressive interest groups are scrambling to marshal their forces to oppose Gorsuch’s confirmation.

Judge Gorsuch has a notably strong record on one controversial subject, that being on church-state matters. His rulings have generally supported a more “accommodationist” approach to resolving church-state controversies, a position advocated by religious conservatives. In addition, during the White House announcement ceremony for his nomination, Judge Gorsuch remarked that he was “thankful for my family, my friends, and my faith.”

His statement raises the question of whether a judge is influenced to rule a particular way on church-state controversies by his or her religious faith.

I am a constitutional law professor who specializes in church and state matters. I have also participated in more than 25 church-state cases before the Supreme Court as counsel and through friend-of-the-court briefs.

In my view, the religious faith of a justice, standing alone, tells us little about how he will vote in church-state cases or on other controversial social issues. It is a conservative religious worldview that is more likely to reinforce and validate an existing conservative judicial ideology.

Gorsuch’s judicial decisions

Following Trump’s announcement, conservative religious groups such as Focus on the Family and the Family Research Council praised Gorsuch’s nomination. The evangelical magazine Christianity Today declared that Gorsuch will be a justice “that evangelicals will love.” In contrast, progressive religious groups have voiced opposition to Gorsuch’s nomination based on his church-state holdings.

Little is known about Gorsuch’s personal faith other than that he is religiously observant. Gorsuch was raised Catholic, attending a private Jesuit school in his youth. He became an Episcopalian while a graduate student at Oxford, the religion of his wife whom he met while in England. Currently the judge attends a mainline Episcopal church in Boulder, Colorado, that takes progressive stances on social issues.

The liberal orientation of Gorsuch’s church stands in contrast to his own record of judicial decision-making. During his 10-year tenure on the Tenth Circuit Court of Appeals, Gorsuch has taken a firm stance on behalf of protecting religious liberty claims against government regulations, a position that has made him a favorite of religious conservatives. Several of those cases have been highly controversial.

Protesters rally outside the Supreme Court against President Donald Trump’s Supreme Court nominee Neil Gorsuch in Washington, D.C. on Jan. 31. Yuri Gripas

The infamous Hobby Lobby case is one example. In that case, the Supreme Court held that for-profit corporations may assert a religious liberty defense against having to comply with the contraceptive care insurance mandate under the Affordable Care Act. Judge Gorsuch wrote a concurring opinion in the Tenth Circuit’s decision that went even further, urging that courts should defer to a person’s subjective claim that a law burdens his religious beliefs, regardless of how tangential that burden appears objectively.

Little Sisters of the Poor is another example of a case that involved the question of a religious exemption from complying with the ACA. In that case, the Catholic order that operates nursing homes claimed that even applying for an exemption under the ACA from the government violated their religious beliefs. Gorsuch dissented when the Tenth Circuit declined to reconsider its decision rejecting the Little Sisters’ religious liberty claims. That dissent argued that the court had given insufficient deference to the Little Sisters’ own articulation of the burden on their religious beliefs.

He has also written or joined on opinions siding with the ability of governments to display religious symbols on public property, such as a Ten Commandments monument on courthouse lawns. According to one bipartisan analysis of Gorsuch’s record:

“The common thread in these cases is one that matters very deeply to conservatives: a sense that the government can permit public displays of religion – and can accommodate deeply held religious views – without either violating the religion clauses of the Constitution or destroying the effectiveness of government [nondiscrimination] programs.”

Religious affiliations in Supreme Court

The question many people are asking is, will Gorsuch’s religious affiliation matter? First, let’s look at the religious makeup of the Supreme Court.

Currently, the Supreme Court comprises five Catholics and three Jews (Justice Scalia was also Catholic). This has led some commentators to speculate on what this means for issues such as abortion regulations and church-state matters.

The vast majority of justices have been Protestants, which is not surprising considering the Protestant dominance of the culture until recently. President Andrew Jackson appointed the first Catholic to the Supreme Court (Chief Justice Roger Taney) in 1836, a fact that did not go unnoticed. The next Catholic justice, Edward D. White, was appointed in 1894, some 58 years later. (White was more controversial for being a former Confederate officer than for being Catholic)

The first Jewish justice was appointed in 1916 (Louis Brandeis), to be followed by Benjamin Cardozo in 1932, which established the unofficial “Jewish seat” on the court. From 1940 forward, there has always been at least one Catholic and one Jewish justice on the high court (absent a hiatus from 1969 to 1993 of a Jewish justice).

Those demographics have changed significantly over the past two decades. With the resignation of Justice John Paul Stevens in 2010, the court was left without a Protestant member for the first time in its history.

Here’s what history tells us

In most instances, research shows, a justice’s religious faith has been a poor predictor of his or her judicial philosophy (and that would assume that one can draw accurate conclusions about what any religion requires of its adherents).

For example, is it safe to assume that a Catholic justice will vote against abortion and gay marriage because of the teachings of the Catholic Church?

Catholic Justice Frank Murphy (1940-1949) was a staunch New Deal liberal, whereas Catholic Justice William Brennan (1956-1990) was likely the Supreme Court’s fiercest supporter of church-state separation and reproductive choice during his long tenure.

Currently, Catholic Justice Sonia Sotomayor is considered to be part of the court’s liberal wing. Another notable liberal was Justice Hugo Black (1937-1971), who was a Southern Baptist, while two conservative justices were William Howard Taft (1921-1930) (Unitarian) and William Rehnquist (1972-2005) (Lutheran).

And though Catholic Justice Anthony Kennedy usually sides with the conservatives, he has voted to uphold abortion rights and gay marriage. Likely the closest religious indicator of judicial philosophy has been among the court’s Jewish justices, who have overwhelmingly been liberal.

To be sure, there have been some exceptions. Justice William Strong (1870-1880) was an evangelical Presbyterian who served briefly as president of a religious organization that sought to amend the Constitution to declare the United States a “Christian nation.”

Similarly, Justice David J. Brewer (1889-1910) was an evangelical Congregationalist who declared in a court opinion that America was a Christian nation, a matter he wrote about at length off the bench. And Justice Felix Frankfurter (1938-1962), a secular Jew, frequently referenced his religious/ethnic heritage in his strong support for church-state separation.

But those instances have generally represented the exceptions.

The safest conclusion to draw from history is that religious affiliation is probably a poor indicator of judicial philosophy. It generally does not preordain any judicial holdings. However, a conservative religious outlook may reinforce an existing conservative judicial ideology, and vice versa, particularly on social issues.

Steven K. Green, Professor of Law, Director of the Center for Religion, Law & Democracy, Willamette University

This article was originally published on The Conversation.

Library Of Congress Opens Applications for Teacher-in-Residence

March 10, 2017

WASHINGTON, DC – The Library of Congress is seeking applications from current world history or world geography teachers for a Teacher-in-Residence position within its Educational Outreach division during the 2017-18 school year.

The program description and application details for the position can be found at loc.gov/teachers/newsevents/teacher-in-residence/. Applications are due Monday, April 17.

The Educational Outreach division develops and delivers teaching materials and programs to make the Library’s unparalleled collections of primary sources visible, accessible and easy for K-12 teachers to integrate into the classroom.

The Library of Congress Teacher-in-Residence program is designed to give the selected educator a unique professional development experience—a year at the Library in Washington, D.C., working side-by-side with staff, contributing to K-12 education programs and materials, advising on outreach to teachers and helping to uncover and make visible primary sources in the Library’s collections.

The Teacher-in-Residence program has been in place since 2000, but this is the first year the Library has specifically recruited a world history or world geography teacher.

In addition to assisting Library of Congress staff, the teacher-in-residence will undertake a project using Library primary sources to benefit his or her home school, district or institution, to be implemented during the following academic year. This project could be a workshop on teaching with primary sources for fellow teachers, a district-wide social media campaign to promote teaching with the Library’s primary sources, the design of a new collaborative curriculum unit, or some other product or activity.

The Library of Congress is the world’s largest library, offering access to the creative record of the United States—and extensive materials from around the world—both on site and online. It is the main research arm of the U.S. Congress and the home of the U.S. Copyright Office. Explore collections, reference services and other programs and plan a visit at loc.gov, access the official site for U.S. federal legislative information at congress.gov, and register creative works of authorship at copyright.gov.

Why Trump’s ‘Skinny’ Budget is Already Dead

Roy T. Meyers,
University of Maryland, Baltimore County

March 9, 2017

The Trump administration is about to formally lay out its spending priorities for the country in its first budget proposal. The Conversation

Some of the outlines are already out there, signaling a massive increase in military appropriations that will be offset by deep cuts to other discretionary spending, including foreign aid, the National Endowment for the Arts and the Coast Guard. President Donald Trump himself touched on some of these themes in his recent speech before Congress.

But some key Republicans wasted little time before deeming the president’s budget blueprint “dead on arrival,” with Senator Lindsey Graham calling it “politically unrealistic.”

A more apt description, however, might be “dead before arrival.”

Why would that be? Partly because it’s challenging to craft a budget during a transition year. More importantly, however, it’s because Trump’s proposal combines a slap-dash process with heavy-handed non-defense-spending cuts.

How the budget process works

While Congress is ultimately responsible for writing the federal budget – which last year contained about US$4 trillion in spending – the legally mandated proposal provided by the executive branch is essential to getting it done. That’s because Congress does not have the capacity to replace the extensive work done by all the departments when they prepare the president’s annual budget request.

Current law requires that the president send his budget to Congress by the first Monday in February. During transition years, however, that usually gets pushed to April or May because it takes a while for incoming presidents to staff key positions. This delay happens despite the fact that the Office of Management and Budget (OMB) includes hundreds of professional examiners who exemplify the practice of “neutral competence” – providing expert analysis to both Democratic and Republican presidents.

In fact, prior to 1990, lame duck presidents submitted their own budget blueprints because Congress required one before Inauguration Day, and their successors either edited it a bit or, in a couple cases, left it as is.

But after the deadline was extended in 1990, the past three presidents have had to hastily assemble their own vision for the country, largely from scratch, in what eventually became known as a “skinny budget,” meaning it skimped on many of the usual details.

Now it’s Trump’s turn to propose a budget for fiscal year 2018, which starts Oct. 1. Trump’s skinny budget, expected to come out around March 16, will be a lot skinnier than usual.

Sneak previews

The announced focus of Trump’s budget will be on discretionary spending, which for fiscal year 2017 is projected to total $1.2 trillion, or about 30 percent of the overall budget (the rest includes Social Security, Medicare and other mandatory spending such as interest payments on the national debt). About half of discretionary spending funds the military, while the rest pays for a wide range of programs from education to environmental protection.

Most notably, Trump reportedly wants to increase defense spending by $54 billion and fully offset that amount by cutting other discretionary programs. According to OMB Director Mick Mulvaney:

“It reduces money that we give to other nations, it reduces duplicative programs, and it eliminates programs that simply don’t work.”

While Mulvaney declined to describe where exactly those cuts would fall, elements of the plan have leaked. Examples include a 69 percent cut to the EPA’s spending on climate change and 78 percent for its environmental justice programs. These cuts are designed, it seems clear, to reduce the ability of the government to regulate business groups that have supported the Republican Party.

But some cuts are already meeting strong resistance. Even Trump’s hand-picked Environmental Protection Agency director, Scott Pruitt – who as Oklahoma attorney general repeatedly sued the agency he now runs – has voiced opposition to the reduced EPA spending.

A closer look at the process of how these plans were reached reveals a significant flaw and the reason this budget will not be acceptable to Congress.

A top-down process

The process of creating a spending blueprint typically begins during “budget season” – October through December – when government agencies submit their wish lists to the OMB, which then compares requests with the president’s desired policies and edits them as necessary.

That didn’t happen during this transition, because the Obama administration – as sometimes happens when there’s a change in government – asked departments only to submit estimates of continuing current policies rather than the usual full requests that would have been reviewed by the outgoing government. That gave Trump’s team a slow start, which was made worse by the transition’s delays in identifying key political appointees.

Yet the overall direction of the budget was still set at the top by the president. OMB Director Mulvaney summed up how this budget was prepared this way:

“We are taking his words and turning them into policies and dollars.”

In reality, however, as is clear from a reading of what is proposed, Mulvaney has relied on conservative advocacy organizations such as the Heritage Foundation to identify many of those specific “policies and dollars.”

That groups affiliated with the incoming president have such influence is nothing new. What is different this time is that their proposals did not receive much of a vetting.

In the typical process, the budget requests that have been trimmed by OMB analysts are sent back as “passbacks” to originating departments for potential appeal, giving them a chance to explain why certain spending or programs are necessary. But when Mulvaney revealed the outline of his budget, he made the remarkable admission that the OMB had not yet delivered its passbacks to the departments – less than three weeks before the budget would be released.

The bottom line is that the White House publicized a target of $54 billion (11 percent of 2017 discretionary spending) in cuts without receiving any feedback from agencies about the feasibility of making them. Further, because the administration and Congress have also already called for increases in spending in certain areas – such as veterans health programs, doubling the number of border patrol agents and infrastructure investments – that means the $54 billion hammer will fall even harder on everything else.

Hence the negative reaction from Congress, which understands how politically popular many of the programs targeted for cuts are. Some previous proposals to impose similar cuts were defeated, such as in the successful campaign to “save Big Bird.”

After all, non-defense appropriations have already been cut greatly since 2010, when they tallied an inflation-adjusted $612 billion. Spending caps adopted in 2010 placed a ceiling of $516 billion for such spending. Trump’s budget would drop it further to $462 billion.

So even though Trump’s skinny budget will propose big cuts – and some will be adopted – Congress will not rubber-stamp many of them.

And oddly, there was no reason to rush in the first place.

The government is currently running on a continuing resolution for fiscal year 2017 after Republicans decided not to pass regular appropriations bills – which were supposed to be enacted by last October – until after President Trump took office. That continuing resolution expires on April 28.

So Congress will need to pass 2017 appropriation bills before it can even look at the 2018 budget. Clearly the administration could have taken its time before releasing its proposal.

Budgets are complicated too

In other words, the lack of substance combined with politically toxic spending cuts mean Trump’s first budget blueprint stands little chance of full adoption.

Over the rest of the year, if Republicans are to enact a full budget for 2018, there will have to be a meeting of the minds between Congressional Republicans and President Trump – which currently seem very far apart on key issues.

Most Republicans tend to advocate for a balanced budget and debt reduction. In contrast, the nonpartisan Committee for a Responsible Federal Budget estimated before the election that adopting all of Trump’s campaign promises – including tax cuts, the “wall” and infrastructure spending – would increase the public debt to 105 percent of GDP from 86 percent today. And that’s in part because he’s also promised not to touch entitlements like Social Security and Medicare.

There are also large differences between Trump and Republican lawmakers on how to change the tax code, how to replace the Affordable Care Act and whether to subsidize corporations for creating jobs.

To date, Trump has not shown much facility to resolve these budgetary conflicts – or in the realization that some subjects, like this and health care, are in fact very complicated. And so in the absence of presidential leadership that wrestles with the complexities of government, don’t expect his skinny budget to provide a consistent vision for the nation – or to have a future.

Roy T. Meyers, Professor of Political Science and Affiliate Professor of Public Policy, University of Maryland, Baltimore County

This article was originally published on The Conversation. Read the original article.

Gerber Issues Allergy Alert To Clarify Egg Labeling For Cheese Ravioli Pasta Pick-ups®

 

March 9, 2017

Gerber Products Company of Florham Park, New Jersey, is initiating a voluntary recall of Cheese Ravioli Gerber® Pasta Pick-Ups® because the egg allergen is missing from the “Contains” statement. The full ingredient list on the package does list “egg” as an ingredient; however, the “Contains” statement, designed to further alert parents to allergens in the recipe, did not include “egg” as is required. Only consumers who have an allergy or severe sensitivity to egg are at risk of serious allergic reaction if they consume this product.

Cheese Ravioli Gerber® Pasta Pick-Ups® (UPC code: 159070) was distributed nationally through retail stores and ecommerce and is limited to the United States. This voluntary recall impacts all packages of the Cheese Ravioli variety of Gerber® Pasta Pick-Ups®. All other Gerber products, including other Gerber® Pasta Pick-Ups® varieties, are appropriately labeled.

To date, no illness has been reported due to an allergic reaction to egg.

This labeling oversight was brought to our attention as a result of a consumer contact. Following our own internal review, we confirmed egg was included in the ingredient list, but was not listed in the “Contains” statement.  Gerber is in the process of updating its food package labels to make it easier for parents to identify foods that contain allergens such as egg, milk and wheat. On updated packages, this information can be found in the “Contains” statement as well as the ingredient list.

Gerber regrets this oversight on our label. We encourage parents who have questions to contact us 24/7 at 1-800-510-7494.

About Gerber
Gerber was founded in 1928 in Fremont, Michigan. Gerber Products Company joined the Nestlé family on September 1, 2007. Gerber Products Company is a leader in early childhood nutrition.

This St. Patrick’s Day… Plan Before You Party

If you are planning on participating in St. Patrick’s Day festivities, don’t forget to plan for a sober ride home after the celebration. Volunteer to be the sober driver; plan for a sober ride home; plan for that extra guest to spend the night; collect the keys—in short, do what it takes to ensure a safe and fun-filled St. Patrick’s Day. In 2015 alone, 10,265 people were lost to drunk driving deaths and exponentially more lives were forever changed by the loss of a parent, child, friend, or loved one.

As preparation for the celebration, NHTSA would like to invite you to a Twitter Chat on March 16, 2017 from 3-4 p.m. ET to provide stats and information on buzzed driving prevention. Experts will be available to answer questions while you spread the word and encourage your followers not to drive buzzed. We’ve also got plenty of other resources available for you to help spread this life-saving message far and wide.

Who: NHTSA and our team of experts

What: St. Patrick’s Day Buzzed Driving is Drunk Driving Twitter Chat

When: Thursday, March 16, 2017, 3 – 4 p.m. ET

Where: www.twitter.com/NHTSAgov 

How: Follow the conversation using the hashtag #BuzzedDriving. Feel free to mention @NHTSAgov in any of your tweets and we will get back to as many questions and comments as we can! Remember to include #BuzzedDriving in your comments so others can follow the conversation, too.

Invite your friends and followers to join us and help spread the important message about designating a sober driver and not getting behind the wheel while buzzed. Buzzed driving is completely preventable. All it takes is a little planning. Don’t rely on luck this St. Patrick’s day—get a sober ride home.

The Soynut Butter Co Expands Recall to All I.M. Healthy Soynut Butters And I.M. Healthy Granola Because of Possible Health Risk

March 7, 2017

SILVER SPRING, MD – The SoyNut Butter Co. of Glenview, IL is recalling all varieties of I.M. Healthy SoyNut Butters and all varieties of I.M. Healthy Granola products because they may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7). E. coli O157:H7 causes a diarrheal illness often with bloody stools. I.M. Healthy Products were distributed in multiple states and may have been purchased in stores or through mail order. They were also distributed to childcare centers and schools in multiple states.

All Best Buy dates of all varieties are affected. I.M. Healthy SoyNut Butter has been packaged in 15 oz plastic jars, individual portion cups, 4 lb plastic tubs, or 45 lb pails. SoyNut Butter is available in Original Creamy, Chunky, Honey Creamy, Unsweetened and Chocolate. The granola has been packaged in individual serving packages, 12 oz bags, 50 oz bags, and 25 lb bulk bag. I.M. Healthy Granola is available in Original, Apple, Blueberry, and Raisin and Cranberry. Best Buy dates can be seen on the labels of the containers stamped in silver or black.

Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called Hemolytic Uremic Syndrome (HUS). HUS is most likely to occur in young children and the elderly. The condition can lead to serious kidney failure and even death.

The recall was initiated after ill people or their family members answered questions about the foods they ate and other exposures in the week before they became ill. Nine (100%) of the nine people reached for interview reported either eating I.M. Healthy brand SoyNut Butter at home (five people) in the week before they became ill or attending a childcare center that served I.M. Healthy brand SoyNut Butter.

Consumers who have purchased I.M. Healthy SoyNut Butter products or I.M. Healthy granola products are urged not to consume the product and return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-288-1012, Monday-Friday 9:00-5:00 CST.

A and H Focal Inc. Issues Nationwide Recall of 29 Products Marketed as Dietary Supplements For Male Enhancement

March 7, 2017

A&H Focal Inc. is voluntarily recalling all lots of the following products because many of these products have been historically tested by the FDA and found to contain PDE-5 Inhibitors (i.e. sildenafil, tadalafil, vardenafil, etc.) which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED) making these tainted dietary supplements unapproved drugs.

These undeclared active ingredients poses a threat to consumers because the PDE-5 Inhibitors 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.

  • Black Ant (4600 mg)
  • Indian God Lotion
  • Evil Root (1200 mg)
  • Germany Black Gold (2800 mg)
  • Germany Niubian (3000 mg)
  • Hard Ten Days (4500 mg)
  • Lang Yi Hao (Chaonogsuopian) (500 mg)
  • Gold Vigra
  • Clalis
  • Ye Lang Shen (5000 mg)
  • Zhansheng Weige Chaoyue Xilishi (2000 mg)
  • Zhonghua Niubian (2000 mg)
  • Stree Overlord (3800 mg)
  • Max Man (3000 mg)
  • Hu Hu Sheng Wei
  • Tiger King
  • Viagra 100 (2000 mg)
  • Power V8 Viagra (200 mg)
  • Dadiyongshi Xiangganglongshengwu
  • Lien Chan for Seven Days
  • Maca Gold (6800 mg)

These products were marketed as dietary supplements for male sexual enhancement.  All lots of the listed products sold by A&H Focal Inc. since January 2014 to present are included in this recall.  The products were mainly sold through Asian Markets located in NJ and NY.

Consumers who have any of the above mentioned products should immediately stop use of the product and properly discard.  If you have further distributed this product please notify those individuals of this recall.

Consumers with questions regarding this recall can contact Mr. Henry Choo by calling 646-327-8522, Monday through Saturday, 9am-6pm, EST.  Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall and market action are being conducted with the knowledge of the U.S. Food and Drug Administration.