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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
WAYNE COUNTY — Four children were killed when a semi struck a car that was slowing in a construction zone on an Indiana interstate Thursday evening.It happened shortly after 5 p.m. on eastbound I-70 in Wayne County, about 70 miles east of Indianapolis.According to Indiana State Police, troopers arrived to find a Chevrolet car and a semi pulling a box trailer both on fire, just west of a construction zone.State police investigators believe the truck did not slow down when it came upon slowed traffic near the construction zone and slammed into the back of a car, pushing it into another semi.Witnesses told the Wayne County Sheriff's Office that the driver of the semi that struck the car from behind was operating in an "erratic manner" prior to the crash. Investigators say evidence revealed that stopped traffic was not a contributing factor to the crash.Preliminary toxicology reports indicated that the driver had multiple drugs in his system at the time of the crash. He was arrested and lodged into the Wayne County Jail on the following preliminary charges:Four counts of reckless homicideFour counts of operating while intoxicated causing deathOperating while intoxicated causing serious bodily injuryIndiana State Police say a passerby was able to pull the driver of the passenger car out of the vehicle, but none of his passengers.State police say four children inside the vehicle were all pronounced dead at the scene. They have been identified as:Anesa Noelle Acosta, 15Quintin Michael McGowan, 13Brekkin Riley Bruce, 8Trentin Beau Bruce, 6The driver of the passenger car, a 34-year-old man with a Kansas City, Missouri, address, was airlifted to Indianapolis where he was admitted to the burn unit in critical condition, according to the Wayne County Sheriff's Office.The driver of the semi is a 33-year-old man from Ohio. He escaped his burning truck and was taken to a hospital in Richmond. The driver of the second semi was uninjured.The preliminary criminal investigation by the Wayne County Sheriff’s Office indicates that drugs were a contributing factor in causing the crash and that criminal charges are forthcoming.I-70 eastbound remained closed nearly 12 hours and was reopened around 5 a.m. Friday morning.This story was originally published by Katie Cox at WRTV. 2300
WASHINGTON (AP) — Straining to stave off threatened U.S. tariffs, Mexican and American officials claimed progress in White House talks late Wednesday, but President Donald Trump declared it was "not nearly enough" to halt the import taxes he is holding out as a way to force Mexico to stanch the flow of illegal migrants at America's southern border.Talks continued into the night at the State Department and were to resume Thursday.Underscoring the scope of the border problem, the Department of Homeland Security announced separately that U.S. Border Patrol apprehensions of migrants illegally crossing the border hit the highest level in more than a decade in May: 132,887 apprehensions, including a record 84,542 adults and children together, 36,838 single adults and 11,507 children traveling alone.Trump, renewing his threat of import taxes on all Mexican goods, tweeted from Ireland that the Washington talks would continue "with the understanding that, if no agreement is reached, Tariffs at the 5% level will begin on Monday, with monthly increases as per schedule."Mexican Foreign Secretary Marcelo Ebrard said immigration, not tariffs, was the main focus at the White House meeting, which included Secretary of State Mike Pompeo, Vice President Mike Pence and other U.S. officials."We are optimistic," he said at a news conference at the Mexican Embassy.Meanwhile, Republicans in Congress are threatening their own confrontation with Trump, warning the White House that they are ready to stand up to the president to try to block his tariffs, which they worry would spike costs to U.S. consumers, harm the economy and imperil a major pending U.S.-Mexico-Canada trade deal .Without a deal, the first tariffs — 5% taxes on imports from Mexico, eventually increasing to 25% — are to go into effect next Monday, and Trump has said that is "more likely" than not to occur despite the stiff and vocal opposition from many fellow Republicans. His goal is to persuade Mexican leaders to do more to keep would-be migrants from other Central American countries from traveling across Mexico to the American border.Most are from Guatemala, Honduras and El Salvador, countries wracked by gangs, violence and poverty. Many of the travelers are expected to eventually request asylum.The tariffs carry enormous economic implications for both countries, and politically they underscore a major ideological split between Trump and his party. Trump has increasingly relied on tariffs as a bludgeon to try to force other nations to bend to his will, dismissing warnings, including from fellow Republicans, about the likely impacts on American manufacturers and consumers.Administration officials have said Mexico can prevent the tariffs by securing its southern border with Guatemala, cracking down on criminal smuggling organizations and entering into a "safe third country agreement" that would make it difficult for those who enter Mexico from other countries to claim asylum in the U.S.The U.S., however, has not proposed any concrete benchmarks or metrics to assess whether the U.S. ally is sufficiently stemming the migrant flow from Central America. And it is unclear whether even those steps would be enough to satisfy Trump on illegal immigration, a signature issue of his presidency and one that he sees as crucial to his 2020 re-election campaign.GOP Sen. Ron Johnson of Wisconsin said Wednesday he called the Mexican ambassador to underscore that Trump was "serious" about the tariffs and that it's unclear if Congress would be able to muster enough votes to block them from a presidential veto."I just wanted to make sure the Mexican ambassador realized" the situation, Johnson said. "If he enacts those tariffs, they're not going to be overridden."On a hopeful note, White House trade adviser Peter Navarro said on CNN that there were commitments Mexico could make to avoid the tariffs, which he said "may not have to go into effect precisely because we have the Mexicans' attention."Republican Chuck Grassley of Iowa, chairman of the Senate Finance Committee, said before the White House meeting that the Mexicans had "a long list of things they're going to offer to us, and it will preclude tariffs going into effect."Senate Majority Leader Mitch McConnell said Tuesday with understatement, "There is not much support in my conference for tariffs, that's for sure.""Deep concern and resistance," is how Sen. Ted Cruz of Texas characterized the mood.House Speaker Nancy Pelosi, a California Democrat, warned on Wednesday that the proposed tariffs would be "punishing" for both the U.S. and Mexico.Analysts were not optimistic that the initial phase of tariffs could be avoided."Trump has got his new tool and he wants to use it and he will use it ... because it's part of his negotiation tactics," said Duncan Wood, director of the Mexico Institute at the Wilson Center think tank in Washington."Mexico will offer to do a lot more on migration, but they will also say that they will retaliate against tariffs and a lot of people are going to lose a lot of money," he said.Tony Wayne, a former U.S. ambassador to Mexico, said the two sides could have a good meeting and reach a deal, but still not satisfy the "wild card" president."The tweets have said 'stop everybody' and 'stop drugs.' That would be an impossible task to do in the near term," he said.The stakes are clear: The 25-year-old North American Free Trade Agreement made trade with Mexico largely duty free. As a result, manufacturers have built up complicated supply chains that straddle the border. Americans bought 8 billion worth of Mexican imports last year, led by cars and auto parts. Mexico is America's No. 2 export market behind Canada.The back-and-forth could also imperil the NAFTA revamp, which Trump pressured Mexico and Canada to agree to last year. The U.S.-Mexico-Canada Agreement has been signed by all three countries but must be approved by their legislatures.___Associated Press writers Paul Wiseman, Lisa Mascaro, Darlene Superville and Padmananda Rama contributed to this report. 6081
WASHINGTON (AP) — President Donald Trump says he opposes additional funding for the U.S. Postal Service, acknowledging that his position would starve the agency of money Democrats say it needs to process an anticipated surge in mail-in ballots during the coronavirus pandemic.The Republican president said Thursday on Fox Business Network’s “Mornings with Maria” that among the sticking points over a new virus relief package were Democrats’ demand for billions of dollars to assist states in protecting the election and to help postal workers process mail-in ballots.Trump said Democrats are asking for .5 billion for universal mail-in voting and billion for the Postal Service“They need that money in order to have the post office work so it can take all of these millions and millions of ballots,” Trump said in the call-in interview. “If they don’t get those two items, that means you can’t have universal mail-in voting because they’re not equipped to have it.” 980
WASHINGTON, D.C. – The U.S. Postal Service has launched a new website to help Americans vote by mail in the November general election.The USPS announced the creation of usps.com/votinginfo Friday, saying the site is meant to provide the electorate with clear and concise information about voting by mail.The website is also meant to help election officials as states choose to expand mail-in voting options for the upcoming elections, so that voters don’t have to risk contracting the coronavirus at the polls.For domestic voters, the website provides direct links to federal election resources as well as links to state-specific resources. For overseas and military voters, the new site provides additional information, including links to resources supporting their election participation.The site also highlights what the USPS views as the most critical information for voters who opt to vote through the U.S. mail: that, in requesting or casting a mail-in ballot, they not only must comply with their local jurisdictions’ requirements, but also should start the process early.To allow sufficient time for voters to receive, complete and return ballots via the mail, the USPS strongly recommends that voters request ballots at the earliest point allowable, but no later than 15 days prior to the election date.The Postal Service also recommends that voters mail their ballots at least one week prior to their states’ due dates to allow for timely receipt by election officials.Voters should contact their local election officials for further information about deadlines and other requirements.The USPS says it remains fully committed to fulfilling its role in the electoral process and can handle the anticipated increase in election mail.“Election officials and voters are being asked to be mindful of the Postal Service’s established delivery standards and consider how the mail actually works, so that voters have adequate time to request, receive, complete and send their mail-in ballots,” wrote the USPS in a press release. “The Postal Service will continue to do everything in its power to efficiently handle and deliver Election Mail, including ballots, in a manner consistent with the proven processes and procedures that have been relied upon for years.” 2273