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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, D.C. -- For Steve and Linda Trilling, it’s a trying time: balancing fears of the coronavirus and awaiting the chance for Steve to get a kidney transplant.“Everything got pushed back,” he said.Steve is fortunate, though – he found a match in a living donor. The problem is that the coronavirus caused most hospitals to temporarily stop transplant surgeries. Steve’s wife, Linda, who is a nurse, understands why.“I want him to be off a dialysis. I want him to be healthy again,” she said. “I also want it to be in a safe atmosphere.”The issue goes beyond just waiting for surgeries to resume.Right now, more than 112,000 people are awaiting an organ transplant in the U.S., according to the Health Resources and Services Administration. While most will get an organ from a living donor, approximately one-third, 33%, of all organs used in transplants come from donors who died in motor vehicle accidents. When widespread lockdowns kept people at home and off the road this past spring, those particular organ donations dropped, as did others.David Klassen is with the United Network for Organ Sharing, a nonprofit which manages the nation’s transplantation system through a contract with the federal government.“Starting in about mid-March, organ donation really plummeted fairly abruptly and there is an approximately 50% decrease in the number of organ donors over the course of about two weeks,” Klassen said.Safety measures instituted since COVID-19 emerged include testing organ donors. Klassen remains hopeful the transplant system will begin to return to normal.“Right now, actually, the system is increasing the numbers of transplants and really things are getting fairly close back toward what we saw prior to the pandemic,” he said.However, that may also depend on where you live. Record numbers of coronavirus cases are emerging in states across the South and West, which is straining hospital resources. Just this past week, one of the largest hospital systems in Miami placed some transplant surgeries on hold.For Steve and Linda Trilling, there’s hope his dialysis may become a thing of the past.“It's been a ride, you know, trying to get myself as healthy as I can for when everything happens,” he said.He has a potential transplant surgery date set for later this summer.“We are so blessed, so blessed, that we are, that we have a donor, that we have a goal,” Linda said. “So, that is, I think, my biggest thing, is having him off this lifeline.”“Just trying to get back to normal,” Steve added.It is a normalcy that’s been missing for them far longer than for most. For more information on organ transplants or to become a donor, click here. 2677
WASHINGTON, D.C. — The constellation of polling places across the country forms the backbone of voting in America. Yet, with about 117,000 of them, it doesn’t always run smoothly.“Some of them are commonplace situations, folks who may not know what ID they need to vote,” said Izzy Bronstein, campaign manager with the nonprofit, nonpartisan organization Common Cause.Common Cause is one of several organizations banding together for the nonpartisan effort Protect the Vote to ensure every vote gets counted in the 2020 election.“There are a number of problems we expect this year,” Bronstein said.Among the potential issues: confusion over mail-in ballots, early voting dates, whether ballot witnesses are needed and what polling sites are open, as well as the potential for voter intimidation. Fear of that is rising on the heels of President Donald Trump saying at the first presidential debate, "Go to the polls and watch very carefully."With all of that in mind, Protect the Vote is recruiting thousands of volunteers across the country – 20,000 signed up so far – to be on hand at polling sites to answer voter questions. They will also help get them in touch with attorneys – from the Lawyers Committee for Civil Rights Under Law -- through a nationwide hotline, so they can assist a voter if they run into trouble casting a ballot.“We know that this is a big election with a lot of at stake,” said Suzanne Almeida of Common Cause PA, which is heading up the effort in the battleground state of Pennsylvania.Almeida is quick to point out that their volunteers are not poll watchers, which are people usually affiliated with a particular candidate.Instead, volunteers with Protect the Vote are called poll monitors and are non-partisan.“It is even more incumbent on us, particularly wearing our nonpartisan hat, to make sure that the election runs smoothly, because we know that folks are going to be looking carefully at the results in Pennsylvania,” Almeida said.Other battleground states, like Florida and Wisconsin, can also expect an election spotlight since there have been election-related issues there in the past.“It's about making sure that every voter gets their ballot counted and their voice heard in our democracy,” Bronstein said. “And that's really something we can all come together on.”If you run into any issues while voting, Protect the Vote has set up a nationwide hotline, staffed by attorneys from the Lawyers Committee for Civil Rights Under Law. That number is (866) OUR-VOTE or 866-687-8683For election help in Spanish: 888-VE-Y-VOTA or 888-839-8682.To volunteer as a poll monitor, click here. 2633
WASHINGTON (AP) — The official serving as President Donald Trump’s eyes and ears at the Justice Department has been banned from the building after trying to pressure staffers to give up sensitive information about election fraud and other matters she could relay to the White House, three people familiar with the matter tell The Associated Press.Heidi Stirrup, an ally of top Trump adviser Stephen Miller, was quietly installed at the Justice Department as a White House liaison a few months ago. She was told within the last two weeks to vacate the building after top Justice officials learned of her efforts to collect insider information about ongoing cases and the department’s work on election fraud, the people said.Stirrup is accused of approaching staffers in the department demanding they give her information about investigations, including election fraud matters, the people said. They spoke on condition of anonymity because they were not authorized to publicly discuss the matter.The effort came as Trump continues to level baseless claims that he won the election and alleges without evidence that massive voting fraud was responsible for his defeat to President-elect Joe Biden.Stirrup had also extended job offers to political allies for positions at some of the highest levels of the Justice Department without consulting any senior department officials or the White House counsel’s office and also attempted to interfere in the hiring process for career staffers, a violation of the government’s human resources policies, one of the people said.The Justice Department declined to comment. Attempts to reach Stirrup for comment were not immediately successful. 1686
WASHINGTON D.C. -- (KGTV) -- Former FBI Director James Comey will break his silence Sunday night in an exclusive interview with ABC News.Excerpts from Comey’s book paint Trump as someone who is “unethical, and untethered to truth and institutional values,” according to ABC.Comey went on, saying Trump is "ego-driven and about personal loyalty,” comparing the President a mafia boss.The interview is part of a media tour to promote his book “A Higher Loyalty: Truth, Lies and Leadership.”The exclusive interview is Comey’s first since being fired from the FBI by Trump. The book will officially be released next week.Comey has faced harsh criticism from both Republicans and Democrats and his book gives him a chance to defend his actions, according to CNN.In July of 2016, Comey announced that he wasn’t recommending charges against Clinton, but stated that Clinton and her aides were “extremely careless” in their handling of classified information.Comey also spoke in the interview about having to confront Trump about allegations against him."I started to tell him about the allegation was that he had been involved with prostitutes in a hotel in Moscow in 2013," Comey says in the clip.Comey characterizes the situation as surreal. "I'm about to meet with a person who doesn't know me, who has just been elected the president of the United States ... and I'm about to talk to him about allegations that he was involved with prostitutes in Moscow and that the Russians taped it and have leverage over him."In a Sunday-morning tweet, Trump called Comey a “slimeball” while criticizing his handling of the email probe. 1628