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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 Trump administration says people would drive more and be exposed to increased risk if their cars get better gas mileage, an argument intended to justify freezing Obama-era toughening of fuel standards.Transportation experts dispute the arguments, contained in a draft of the administration's proposals prepared this summer, excerpts of which were obtained by The Associated Press.The excerpts also show the administration plans to challenge California's long-standing authority to enact its own, tougher pollution and fuel standards.Revisions to the mileage requirements for 2021 through 2026 are still being worked on, the administration says, and changes could be made before the proposal is released as soon as this week.RELATED: California sues over plan to scrap car emission standardsThe Trump administration gave notice earlier this year that it would roll back tough new fuel standards put into place in the waning days of the Obama administration. Anticipating the new regulation, California and 16 other states sued the Trump administration in May.Overall, "improvements over time have better longer-term effects simply by not alienating consumers, as compared to great leaps forward" in fuel efficiency and other technology, the administration argues. It contends that freezing the mileage requirements at 2020 levels would save up to 1,000 lives per year.New vehicles would be cheaper — and heavier — if they don't have to meet more stringent fuel requirements and more people would buy them, the draft says, and that would put more drivers in safer, newer vehicles that pollute less.RELATED: EPA moves to weaken Obama-era fuel efficiency standardsAt the same time, the draft says that people will drive less if their vehicles get fewer miles per gallon, lowering the risk of crashes.David Zuby, chief research officer at the Insurance Institute for Highway Safety, said he's doubtful about the administration's estimate of lives saved because other factors could affect traffic deaths, such as automakers agreeing to make automatic emergency braking standard on all models before 2022. "They're making assumptions about stuff that may or may not be the same," he said.Experts say the logic that heavier vehicles are safer doesn't hold up because lighter, newer vehicles perform as well or better than older, heavier versions in crash tests, and because the weight difference between the Obama and Trump requirements would be minimal.RELATED: President Trump, California clash over key issues"Allow me to be skeptical," said Giorgio Rizzoni, an engineering professor and director of the Center for Automotive Research at Ohio State University. "To say that safety is a direct result of somehow freezing the fuel economy mandate for a few years, I think that's a stretch."Experts say that a heavier, bigger vehicle would incur less damage in a crash with a smaller, lighter one and that fatality rates also are higher for smaller vehicles. But they also say that lighter vehicles with metals such as aluminum, magnesium, titanium and lighter, high-strength steel alloys perform as well or better than their predecessors in crash tests.Alan Taub, professor of materials science and engineering at the University of Michigan, said he would choose a 2017 Malibu over a heavier one from 20 years earlier. It's engineered better, has more features to avoid crashes and additional air bags, among other things. "You want to be in the newer vehicle," he said.RELATED: Nearly every governor with ocean coastline opposes Trump's drilling proposalAn April draft from the Trump administration said freezing the requirements at 2020 levels would save people ,900 per new vehicle. But the later draft raises that to ,100 and even as high as ,700 by 2025.Environmental groups questioned the justification for freezing the standards. Luke Tonachel, director of the clean-vehicle program at the Natural Resources Defense Council, said the risk from people driving more due to higher mileage is "tiny and maybe even negligible."Under the Trump administration proposal, the fleet of new vehicles would have to average roughly 30 mpg in real-world driving, and that wouldn't change through 2026.California has had the authority under the half-century-old Clean Air Act to set its own mileage under a special rule allowing the state to curb its chronic smog problem. More than a dozen states follow California's standards, amounting to about 40 percent of the country's new-vehicle market.Asked if he thinks a freeze in U.S. mileage standards is warranted, EPA acting administrator Andrew Wheeler told a small group of reporters at EPA headquarters last week, "I think we need to go where the technology takes us" on fuel standards.Wheeler did not elaborate. Agency spokespeople did not respond when asked specifically if the EPA acting chief was making the case that modern cars could be both fuel efficient and safe.Wheeler also spoke out for what he called "a 50-state solution" that would keep the U.S car and truck market from splitting between two different mileage standards.The Department of Transportation said in a statement that the final fuel economy standards would be based on sound science. The department cautioned that a draft doesn't capture the whole picture of the proposed regulation.The draft said a 2012 analysis of fuel economy standards under the Obama administration deliberately limited the amount of mass reduction necessary under the standards. This was done "in order to avoid the appearance of adverse safety effects," the draft stated.___Krisher reported from Detroit. 5642

WASHINGTON (AP) — Senate Majority Leader Mitch McConnell says the Senate will vote on a trimmed-down Republican coronavirus relief package, though it has a slim chance of passage in the face of Democrats’ insistence for more sweeping aid. He says the GOP will introduce a new targeted proposal, focused on healthcare, education, and economic issues. The Kentucky Republican released the approximately 0 billion measure as senators returned to Washington for an abbreviated pre-election session, as hopes are dimming for another coronavirus relief bill — or much else.McConnell is under pressure from GOP senators in tough reelection races. Those senators are eager to show constituents they are working to ease the pandemic’s strain on jobs and businesses. McConnell’s bill would provide 5 billion to help schools reopen, enact a shield against lawsuits for businesses and others that are powering ahead to reopen, create a scaled-back 0-per-week supplemental jobless benefit, and write off billion in earlier debt at the U.S. Postal Service. There’s billion for a coronavirus vaccine, billion for virus testing and billion to help child care providers reopen. There is additionally billion for farmers.McConnell acknowledged the package he will be putting forward “does not contain every idea our party likes.” And he said it was far less than what Democrats are seeking.But many Senate Republicans are resisting more spending. Talks between top Democrats and the Trump administration broke off last month. 1544

WASHINGTON (AP) — The U.S. has charged two alleged agents of Iran, accusing them of conducting covert surveillance of Israeli and Jewish facilities in the United States and collecting intelligence on Americans linked to a political organization that wants to see the current Iranian government overthrown.Earlier this week, Ahmadreza Doostdar, 38, a dual U.S.-Iranian citizen born in Long Beach, California, and Majid Ghorbani, 59, who has lived and worked in Costa Mesa, California, since he arrived in the United States in the mid-1990s were charged with acting as illegal agents for Tehran. Ghorbani, who was surveilled by U.S. agents, became a legal permanent resident of the United States in 2015.Their arrests come as the Trump administration ratchets up pressure on Iran. The administration recently re-imposed sanctions on Iran to deny Tehran the funds it needs to finance terrorism, its missile program and forces in conflicts in Yemen and Syria.According to a criminal complaint filed in U.S. District Court in Washington, Doostdar allegedly conducted surveillance in July 2017 on Rohr Chabad House, a Jewish student center at the University of Chicago in Hyde Park. The surveillance included security features around the center.Mary Manning Petras, a federal defense lawyer, said a court hearing in the case is set for Sept. 6.Jonathan Greenblatt, national director of the Anti-Defamation League, applauded the arrests and thanked the FBI for "disrupting the alleged intelligence gathering efforts of the Islamic Republic of Iran, a nation with a long record of involvement in, and support for, terror attacks against Jewish and Israeli institutions."In September 2017, Ghorbani allegedly attended a Mujahedin-e Khalq rally in New York City where he photographed people protesting against the current Iranian government.The MEK, despite deep ideological differences, were partners with Ayatollah Ruhollah Khomeini in the 1979 revolution that toppled the U.S.-backed Shah Mohammad Reza Pahlavi. Following the revolution, the MEK quickly fell out with Khomeini and launched an armed revolt against Khomeini's new theocracy. The group is outlawed in Iran and was listed as a terrorist organization by the State Department until 2012.In late 2017, Doostdar returned to the United States from Iran and made contact with Ghorbani in the Los Angeles area. Doostdar allegedly paid Ghorbani about ,000 in cash for 28 photographs taken at the September 2017 rally.The photographs had hand-written annotations identifying the individuals in the photos. These photographs, along with a receipt for ,000, were found concealed in Doostdar's luggage as he transited a U.S. airport on his return to Iran in December 2017.In May, Ghorbani attended the MEK-affiliated 2018 Iran Freedom Convention for Human Rights in Washington. During the conference, Ghorbani appeared to photograph certain speakers and attendees, which included delegations from across the United States. On May 14, Doostdar called Ghorbani to discuss the clandestine ways Ghorbani could use to get the information to Iran."Doostdar and Ghorbani are alleged to have acted on behalf of Iran, including by conducting surveillance of political opponents and engaging in other activities that could put Americans at risk," said John Demers, assistant attorney general for national security.The indictment charged Doostdar and Ghorbani with knowingly acting as agents of the government of Iran without notifying the U.S. attorney general, providing services to Iran in violation of U.S. sanctions and conspiracy. Both defendants were arrested on Aug. 9, pursuant to criminal complaints issued by the U.S. District Court for the District of Columbia.The FBI's field offices in Washington and Los Angeles investigated the case, which is being prosecuted by the national security section of the U.S. Attorney's Office for the District of Columbia and the Counterintelligence and Export Control Section of the National Security Division of the Justice Department.In March, the Justice Department announced charges against nine Iranians accused of working at the behest of the Islamic Revolutionary Guard Corps to steal large quantities of academic data from hundreds of universities in the United States and abroad as well as email accounts belonging to employees of government agencies and private companies. 4374

WASHINGTON (AP) — U.S. health officials have traced a food poisoning outbreak from romaine lettuce to at least one farm in central California.But they cautioned Thursday that other farms are likely involved in the E. coli outbreak and consumers should continue checking the label before purchasing romaine lettuce. Bros.The Food and Drug Administration said 59 people in 15 states have now been sickened by the tainted lettuce. That's seven more cases than previously reported, but regulators said they are fairly confident that the lettuce which first triggered the outbreak has been removed from the market. The FDA told consumers to avoid romaine lettuce just before Thanksgiving.Officials said a water reservoir at Adam Bros. Farms in Santa Barbara County tested positive for the bacterial strain and the owners are cooperating with U.S. officials. Officials from the FDA and the Centers for Disease Control and Prevention have not determined how the water reservoir — which is used to irrigate lettuce — became contaminated.The bacteria can get into water and soil through multiple routes, including waste from domesticated animals or wild animals, fertilizer and other agricultural products.The FDA's Dr. Stephen Ostroff said investigators have linked the tainted lettuce to multiple distributors and processors, suggesting it must have come from several farms.A man who answered the phone at Adam Bros. Farms said he could not comment on the government announcement. According to the company's website, it only grows vegetables products, including broccoli, cauliflower, celery and various types of lettuce.The government also narrowed the source of the outbreak to three California counties: Santa Barbara, Monterey and San Benito. That's down from six California counties under investigation when regulators began warning the public last month.Regulators said people should only buy lettuce with a label listing where and when it was harvested. Lettuce from outside the three California counties that was harvested after November 23 should be safe to eat.Romaine harvesting recently began shifting from California's Central Coast to winter growing areas, primarily Arizona, Florida, Mexico and California's Imperial Valley. Those winter regions weren't yet shipping when the illnesses began.E. coli, the bacteria often associated with food poisoning, usually causes sickness two to eight days later, according to health authorities. Most people with the infection get diarrhea and abdominal cramps. Some cases can be life-threatening, causing kidney failure and seizures.___This version corrects spelling of Adam Bros. Farms, not Adams. 2653

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