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WASHINGTON, D.C. – Two different doses of a thyroid medication are being recalled because they're not potent enough.The Food and Drug Administration announced Thursday that Acella Pharmaceuticals is voluntarily recalling one lot of 15-milligram and one lot of 120-milligram NP Thyroid?, Thyroid Tablets.The products may have as low as 87% of the labeled amount of levothyroxine, which is used to treat hypothyroidism (an underactive thyroid), according to the FDA.The company’s risk statement says patients being treated for hypothyroidism who receive sub potent NP Thyroid may experience symptoms of hypothyroidism, including fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight.“There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development,” wrote Acella. “In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia.”So far, Acella says it has received four reports of "adverse events" for these lot numbers, possibly related to the recall.The products subject to recall are packed in 100-count bottles. Their lot numbers are M327E19-1 and M328F19-3. And their expiration dates are Oct. 2020 and November 2020.The products were distributed nationwide to Acella’s direct accounts, including wholesalers, pharmacies, and health care offices.“Acella is proactively notifying its wholesalers by email and phone to discontinue distribution of the two above referenced lots being recalled and is arranging for return of all recalled products,” wrote the company.Anyone who is currently taking NP Thyroid from the lots being recalled should not discontinue use without contacting their health care provider for further guidance and/or a replacement prescription, according to Acella.Anyone with questions about the recall can email Acella at recall@acellapharma.com or contact a representative at 1-888-280-2044.Click here for more information. 2272
WASHINGTON (AP) — The Supreme Court says it will decide whether President Donald Trump can exclude people living in the U.S. illegally from the census count.Trump’s policy has been blocked by a lower court, which said in September that never in U.S. history have immigrants been excluded from the population count that determines how House seats, and by extension Electoral College votes, are divided among the states.The Supreme Court justices signaled in their order Friday that they will hear arguments in December and issue a decision by early January, when Trump must report the once-a-decade census results to Congress.Trump’s high court nominee, Amy Coney Barrett, could take part in the case if, as expected, she is confirmed by then.Along with its affects on House seats, an accurate census is important because the count is only taken every 10 years and it's used to determine how billions of dollars in federal funding flows into communities every year over the next decade. 993
WASHINGTON (AP) — The standoff over President Donald Trump's billion wall funds deepened Monday, threatening a partial government shutdown in a standoff that has become increasingly common in Washington.It wasn't always like this, with Congress and the White House at a crisis over government funding. The House and Senate used to pass annual appropriation bills, and the president signed them into law. But in recent years the shutdown scenario has become so routine that it raises the question: Have shutdowns as a negotiating tool lost their punch?Monday brought few signs of progress. A partial shutdown that could occur at midnight Friday risks disrupting government operations and leaving hundreds of thousands of federal employees furloughed or working without pay over the holiday season. Costs would be likely in the billions of dollars.Trump was meeting with his team and getting regular updates, said White House spokeswoman Sarah Huckabee Sanders. Trump was also tweeting Monday to keep up the pressure.The president is insisting on billion for the wall along the southern border with Mexico, but he does not have the votes from the Republican-led Congress to support it. Democrats are offering to continue funding at current levels, .3 billion.It's unclear how many House Republicans, with just a few weeks left in the majority before relinquishing power to House Democrats, will even show up mid-week for possible votes. Many say it's up to Trump and Democrats to cut a deal.Senate Minority Leader Mitch McConnell opened the chamber Monday hoping for a "bipartisan collaborative spirit" that would enable Congress to finish its work."We need to make a substantial investment in the integrity of our border," McConnell said. "And we need to close out the year's appropriation process."Meanwhile more than 800,000 government workers are preparing for the uncertainty ahead.The dispute could affect nine of 15 Cabinet-level departments and dozens of agencies, including the departments of Homeland Security, Transportation, Interior, Agriculture, State and Justice, as well as national parks and forests.About half the workers would be forced to continue working without immediate pay. Others would be sent home. Congress often approves their pay retroactively, even if they were ordered to stay home."Our members are asking how they are supposed to pay for rent, food, and gas if they are required to work without a paycheck," said a statement from J. David Cox, Sr., president of the American Federation of Government Employees, the large federal worker union. "The holiday season makes these inquiries especially heart-wrenching."Many agencies, including the Pentagon and the departments of Veterans Affairs and Health and Human Services, are already funded for the year and will continue to operate as usual, regardless of whether Congress and the president reach agreement this week.Congress already approved funding this year for about 75 percent of the government's discretionary account for the budget year that began Oct. 1.The U.S. Postal Service, busy delivering packages for the holiday season, wouldn't be affected by any government shutdown because it's an independent agency.Trump said last week he would be "proud" to have a shutdown to get Congress to approve a billion down payment to fulfill his campaign promise to build a border wall.During his 2016 presidential campaign, Trump promised that Mexico would pay for the wall. Mexico has refused.Democratic leaders Chuck Schumer and Nancy Pelosi, in a meeting last week at the White House, suggested keeping funding at its current level, .3 billion. Trump had neither accepted nor rejected the Democrats' offer, telling them he would take a look."He is not going to get the wall in any form," Schumer said Sunday on NBC's "Meet the Press." He said Republicans should join in the Democrats' offer. "Then, if the president wants to debate the wall next year, he can. I don't think he'll get it. But he shouldn't use innocent workers as hostage for his temper tantrum."One option for lawmaker would be to provide stopgap funding for a few weeks, until the new Congress convenes Jan. 3, when Pelosi is poised to become House speaker.Wyoming Sen. John Barrasso, who is in line to become the No. 3 Republican in the Senate, said suggested a stopgap bill could be one way to resolve the issue or a longer-term bill that includes money for border security. 4448
WASHINGTON (AP) — Senate Majority Leader Mitch McConnell says that he's scheduling a procedural vote on a GOP COVID-19 relief bill for next week. He says aid to hard-hit businesses shouldn't be held up by gridlock involving other aid proposals. The Kentucky Republican says in a statement Tuesday that the Senate will take a test vote Oct. 19 when the chamber returns on Monday."We don’t agree with Speaker Pelosi that “nothing” is better than “something” for workers," McConnell tweeted. "Senators will vote on more relief next week, including more PPP money to stop layoffs. We’ll be able to pass it before we turn to Judge Barrett's nomination unless Democrats block it again." 688
WASHINGTON, D.C. – President-elect Joe Biden will nominate Pete Buttigieg to be his secretary of transportation, the campaign confirmed on Tuesday.Biden formally introduced Buttigieg as his pick to run the agency at an event on Wednesday. According to Biden, if confirmed, Buttigieg would become the first openly gay person to serve in a cabinet position.In his remarks, Buttigieg said he would strive to improve America's crumbling infrastructure and shared stories of growing up in Indiana with ambitions to be an airline pilot."Travel in my mind is synonymous with growth, with adventure — even love. So much so that I proposed to my husband Chasten in an airport terminal. Don't let anybody tell you that O'Hare isn't romantic," Buttigieg said. At 38, Buttigieg falls under the "millennial" generation and would also be the first person of that generation to serve in the cabinet. As head of the Department of Transportation, the 38-year-old would likely play a large role in accomplishing Biden’s goal of passing a sweeping infrastructure bill, which has been pitched as a major job-creator.“Mayor Pete Buttigieg is a patriot and a problem-solver who speaks to the best of who we are as a nation. I am nominating him for Secretary of Transportation because this position stands at the nexus of so many of the interlocking challenges and opportunities ahead of us. Jobs, infrastructure, equity, and climate all come together at the DOT, the site of some of our most ambitious plans to build back better," Biden said.Buttigieg has already made history. During his recent run for president, he became the first openly gay major party candidate to win delegates.The former presidential candidate helped Biden solidify the Democratic nomination when he dropped out of the race before Super Tuesday and endorsed the former vice president, consolidating the moderate vote against progressive Sens. Bernie Sanders and Elizabeth Warren.A long criticism of Buttigieg during the campaign was that he didn't have experience in the federal government. Some say this sort of cabinet position could give him the experience to run for the White House again at a later date. 2170