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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
WAVELAND, Miss. (AP) — Hurricane Sally is slowly closing in on the northern Gulf Coast with powerful winds and weather forecasters are warning of “potentially historic” flooding. Hurricane warnings stretch from Morgan City, Louisiana, to Navarre, Florida. In Alabama on Monday, Gov. Kay Ivey asked for a federal emergency declaration as the weather service warned of a storm surge of more than 9 feet in the Mobile area. The storm reached Category 2 strength with sustained winds of 100 mph Monday afternoon. 517
WATCH REPLAYOne day after announcing his running mate, presumptive Democratic Party presidential nominee Joe Biden appeared alongside Sen. Kamala Harris for the first time since Tuesday’s announcement.The US senator from California ran against Biden among a field of candidates vying for the Democratic presidential nomination. While President Donald Trump said that Harris was “nasty” toward Biden during her presidential campaign, Biden came to Harris’ defense from Trump’s attacks."Is anyone surprised Donald Trump has a problem with strong women?” Biden said.Harris also fired back at the president, this time taking aim on his response to the coronavirus pandemic.“At the president's mismanagement of the pandemic has plunged us into the worst economic crisis since the great depression, and we are experiencing a moral reckoning with racism and systemic injustice that has brought a new coalition of conscience to the streets of our country demanding change,” Harris said. “America is crying out for leadership, yet we have a president who cares more about himself than the people who elected him, a president who is making every challenge we face even more difficult to solve, but here is the good news. We do not have to accept the failed government of Donald Trump and Mike Pence.”Trump's response Wednesday evening?"I was surprised he picked her because of the horrible way she spoke about him, and frankly because she dropped like a rock," he said.Biden reflected on his time as President Barack Obama’s running mate and vice president, and how it guided him toward choosing Harris."When I agreed to serve as President Obama's running mate, he asked me a number of questions, as I've asked Kamala, but the most important one, he said to me, what -- he asked me what I wanted, most importantly,” Biden said. “I told him I wanted to be the last person in the room before he made the important decisions. That's what I asked Kamala. I asked Kamala to be the last voice in the room. To always tell me the truth, and she will. Challenge my assumptions if she disagrees. Ask the hard questions. Because that's the way we make the best decisions for the American people."Harris said she had a strong personal connection through Biden’s son Beau, who died in 2015 from brain cancer. The two formed a bond as they both served as state attorneys general."I learned quickly that Beau was the kind of guy who inspired people to be a better version of themselves,” Harris said. “He really was the best of us. And when I would ask him, where did you get that? Where did this come from? He'd always talk about his dad." 2624
WASHINGTON, D.C. – What police reform proposals will get the endorsement of President Donald Trump and Senate Republicans?While House Democrats have already announced what legislation they are seeking, Republicans in the Senate, as well as the White House, have been more mum.That is expected to change this week.Sen. Tim Scott (R-SC) is working with the White House on what ideas the president could support. Scott is the only African American senator in the Republican caucus.White House officials hinted the president would likely provide more guidance on what he supports and what he doesn't when he travels to Dallas, Texas, on Thursday.CNN reported Wednesday that the president is considering an executive order on police reform, which would not require Congress' approval.“We’re still wrestling with America’s original sin,” said Senate Majority Leader Mitch McConnell, referring to slavery, when he spoke with reporters Tuesday.“We try to get better but every now and then it’s perfectly clear we’re a long way from the finish line,” said McConnell. 1065
WASHINGTON, D.C. (KGTV) -- President Donald Trump Tuesday night delivered a prime-time address to the nation on border security. All major networks, including ABC, CBS, NBC, CNN and Fox News decided to carry the address. The battle over border security and a border wall has led to a partial government shutdown that has, as of Tuesday, lasted 18 days. In comparison, the longest government shutdown was under former President Bill Clinton and lasted 21 days. President Donald Trump said during the address that there is a "growing humanitarian and security crisis" at the U.S.-Mexico border, though crossings have fallen in recent years.RELATED: What the border looks like now, as President Trump asks for wall fundingThe President added that all Americans are hurt by uncontrolled illegal immigration. He says it strains public resources and drives down jobs and wages.The President says among those hit hardest by illegal immigration are African-Americans and Hispanics.The President is trying to convince Americans that the flow of immigrants into the U.S. illegally at the southern border is a crisis.He asserts that the government remains shut down because Democrats won't fund border security.RELATED: San Diego lawmakers respond to Trump's border wall commentsFollowing his address, Democrats Nancy Pelosi and Chuck Schumer stood in a long hallway behind a podium, reinforcing their talking points about misinformation spread by the President. Both Pelosi and Schumer didn't seem to be swayed on whether or not they'd compromise and reopen the government, ensuring that the standoff between Trump and Democrats continues. 1638