Viatris, which Pfizer created in 2020, voluntarily withdrew extended-release products made at a plant in Ireland after an analysis revealed an issue that could affect bioavailability.
Viatris has recalled one batch of the anti-anxiety medicine Xanax XR in the U.S. because it failed a test of the rate and extent of drug release.
The company voluntarily initiated the recall after a batch of bottles containing 60 3-mg tablets of the drug failed dissolution specifications. Drugmakers run dissolution tests to assess the conversion of oral dosage forms into solutions. That conversion determines the bioavailability of the active ingredient and thereby affects the efficacy of the drug product.
Viatris found that the dissolution of a batch of extended-release Xanax manufactured in Ireland diverged from the specifications, triggering the Class II recall. The news comes four years after Viatris pulled 110 bottles of Xanax XR from the U.S. market because of out-of-specification results for dissolution. Pfizer, which used to own the drug, recalled 36,000 bottles of immediate-release Xanax in 2012 over dissolution test results.
The FDA approved Xanax XR in 2003, months before Pfizer acquired the asset as part of its $60 billion takeover of Pharmacia. An immediate-release formulation of the active ingredient, the benzodiazepine alprazolam, was already available. However, the older product needed to be taken three to four times a day. Xanax XR is taken once daily.
Alprazolam was off patent and facing generic competition when the FDA approved Xanax XR. Supported by the extended-release formulation, Pfizer grew sales of its Xanax franchise to $350 million in 2008. By then, generic extended-release alprazolam products were competing for market share.
Actavis launched a generic copy of the drug in 2007. Impax Laboratories, which is now part of Amneal Pharmaceuticals, entered the market months after Actavis. Aurobindo Pharma’s generic won FDA approval in 2011.
Xanax XR was part of Pfizer until the drugmaker merged its Upjohn business with Mylan to form Viatris in 2020. Viatris reported $139.9 million in Xanax sales last year. Sales have slipped in recent years, falling from $154.8 million in 2023 to $145 million in 2024.
Viatris’ Xanax XR withdrawal was one of 30 drug recalls in the FDA’s latest weekly enforcement report, which also included five recalls by Teva Pharmaceuticals. The company withdrew about 30,000 packages of the acne medicine isotretinoin across two recalls because they were superpotent or subpotent. Teva recalled isotretinoinin January, but the FDA only classified the action this month.
Teva’s three other recalls stemmed from the use of an unapproved raw material. The FDA listed Actavis Laboratories as the manufacturer of the recalled batches of Teva’s clonidine transdermal system.
The US Attorney’s Office for the Western District of Washington said on Monday that an Iranian citizen was extradited from Panama to the United States to face a nine-count indictment in Seattle tied to an alleged scheme to violate sanctions against Iran by shipping goods through China.
Reza Dindar, 44, was indicted by a grand jury in August 2014 and arrested in Panama in July 2025 at the request of the United States, the office said in a statement.
Dindar was due to appear in US District Court in Seattle on Monday for an initial hearing, it said.
“The members of this conspiracy thought they could evade export restrictions by shipping goods through a third country – in this case China,” First Assistant US Attorney Charles Neil Floyd said.
According to the indictment, between 2010 and 2014 Dindar managed a business in Xi’an, China, that allegedly concealed the fact it was procuring US goods for companies in Iran.
Prosecutors said Dindar and co-conspirators used deception in 2011 and 2012 to purchase parts for three military sonar systems from a business in Washington state, claiming they were destined for China while intending to ship them onward to Iran.
Dindar is charged with conspiracy, export violations, smuggling, money laundering and filing false export records.
At least 26 vessels linked to Iran’s so-called “shadow fleet” have bypassed the US naval blockade despite Washington’s claims that it has turned back shipping bound for the country, according to maritime intelligence reported by Lloyd’s List.
The report cited tracking data showing continued tanker movements tied to Iranian trade since the blockade began.
Among them were several oil and gas tankers carrying Iranian energy exports that departed the Gulf region despite the restrictions, Lloyd’s List reported.
Iran has long relied on a network of ageing or lightly regulated vessels, often operating with obscured ownership or tracking data, to move oil in defiance of Western sanctions.
The report suggests that even under heightened military pressure, elements of that shadow fleet continue to operate.
New York education officials adopted emergency rules last week mandating that schools set a policy for taking care of young kids’ number ones and number twos — just in time for an expansion of state-funded daycare and pre-K programs.
But nobody wants to be left holding the dirty diaper.
The state’s new “diapering and toileting” requirement for districts has left schools scrambling for clarity over who gets to be on doody duty: teachers, teacher’s aides or nurses?
State officials dropped new rules on “diapering and toileting” in schools.Tomsickova – stock.adobe.com
Some educators wanted nothing to do with doo-doo and argued potty training should remain parents’ responsibility, according to a summary of a state Department of Education question-and-answer session over the rule.
“One commenter indicated that expecting schools to potty train children is ‘unacceptable,’ stating that, unless there is a medical issue, parents should ensure children are toilet-trained before entering school,” the summary reads.
Department of Educations officials maintained, however, that the 2024 law that prompted the new rules said otherwise.
“The Department lacks the authority to require toileting skills as a condition of public school attendance,” officials said in the Q-and-A with educators.
The stink comes as Mayor Zohran Mamdani and Gov. Kathy Hochul joined forces to expand pre-school and daycare programs.
The so-called “free” universal child care proposal, which carries a $4.5 billion price tag, would bring 100,000 more children into programs across the state, including a new “2-Care” initiative for 2-year-olds in the Big Apple.
Even before Mamdani and Hochul began crowing about the benefits for working parents, state officials laid the groundwork for dealing with the messy reality that everyone poops.
The 2024 law aimed to set standards for dealing with toilet issues — but school employees have tried to argue they can’t bear diaper duty.
“Teachers may be stretched too thin without added support and emphasized that adequate staffing and supplies would require additional funding,” the state’s summary reads.
“Others argued that the NYS Learning Standards ‘do not require teachers to provide toilet-training instruction,’ underscoring that schools can support but should not replace the parental role.”
Nurses also weren’t interested in changing soiled pants or diapers, the comments show.
“Some commenters emphasized the importance of defining the role of school nurses, particularly in relation to toileting and toilet training, and recommended that toileting should not be performed by a nurse.’ These commenters maintain that toileting is an activity of daily living (ADL), not a nursing function, noting that hospital nurses have long delegated such tasks to aides,'” the DOE summary said.
The DOE said school districts must decide who will perform dooty duty.
“Decisions on how staff will provide diapering support must be made at the local level, based on local protocols, regulations, and operational needs,” the department said.
Mamdani and Gov. Kathy Hochul are pushing to expand pre-K and 3-K programs.Luiz C. Ribeiro for NY Post
The law was pushed by the New York State United Teachers.
The teachers’ union maintains that School-Related Professionals — commonly known as paraprofessionals — should be responsible for both teaching students how to use the bathroom independently, and for diapering them, changing them, and cleaning up after them.
“Without regulations from the state, some districts have been acting fast and loose with their approaches to this issue,” an NYSUT newsletter states.
One paraprofessional in Rochester complained that her school wanted her to change her student who has autism on the floor.
She was able to get a changing table after lodging a complaint.
The department said school districts will not receive additional funding to comply with the new policy.
“There is currently no additional state funding available for implementation of the proposed statute or rule,” the DOE said.
The rule requires school districts to promote “a safe and healthy environment to support diapering and toileting” and establish a plan with protocols that outlines clear, age-appropriate routines for student privacy, hygiene, and supervision.
Schools will also be required to provide annual training on health and safety procedures to all relevant staff.
The rule requires space for restroom and diaper changing areas and these areas must be consistently maintained, cleaned, and appropriately equipped.
Schools are barred from suspending, expellng or excluding a student from enrollment or participation in school or school programs based on their “toileting status” — or not being potty trained.
Toileting accidents must be handled with “sensitivity and without punishment, exclusion, or shaming,” the rule states.
The edict also requires schools to provide the support, services, and specialized equipment necessary for preschool and school-age students with disabilities who require assistance with toileting, in accordance with their individualized educational program (IEP) or special education plan.
The state Board of Regents is expected to give final approval to the toiletry rule its next meeting after giving providing initial emergency adoption to comply with the timeline under the law.
City education officials said their Division of Early Childhood Education has partnered with the United Federation of Teachers to develop and deliver professional learning resources for staff and teaching teams.
The city’s public schools have established protocols in line with the newly issued diapering the toileting rule, officials said.
What’s the point in dying for your country when, instead of your death
serving as a payment for a prosperous and secure future for your children and culture, your government just hands it over to foreigners who hate you and all that you were? Today, Remix News reported that Ukrainian officials are working on a new plan to replace all their war dead men with third world aliens from the darkest corners of the globe: Islamic Africa.
Well, let be be more clear: Zelensky’s administration isn’t looking to send these newcomer imports to the warfront to really get a full sense of citizenship and national responsibility—that’s a position reserved for the white, Slavic natives—these Africans are going to be sent to Ukraine to fill the jobs left vacant when the Ukrainian fathers, husbands, and brothers reported for duty, or were dragged into a van and hauled off to the battlefield under “mobilization” policies. The role of cannon fodder is exclusively reserved for the Ukrainian men.
Volodymyr Zelensky’s head of his Presidential Office in Ukraine, Kyrylo Budanov, has announced plans to import migrant laborers from Africa. Essentially, this entails Ukraine establishing new laws for the legal entry and residence of foreign workers.
...
It has long been known that Ukraine faces a serious demographic crisis, now exacerbated by men who have died in the war or fled to other countries. Already, there have been voices pushing for mass immigration in Ukraine since the war began. Last year, Remix News reported that Vasyl Voskobojnik, president of the Ukrainian Association of Foreign Employment Agencies, said the population decline can no longer be offset by simply increasing the birthrate. Instead, immigration from Third-World countries is the only solution.
Voskobojnik said the Ukrainian government must develop a migration policy by 2026 that focuses on reducing this shortage.
As for the African men? They’ll get all those non-military positions in the private and/or public sector, far from the danger, complete with government-funded healthcare and pensions, largely thanks to American taxpayers—though it’s a thankless role as gracious benefactor. Ukraine has a public healthcare system, which we taxpayers are routinely forced to prop up, and USAID funds have long been used to pay for government expenses, including pensions (though one of the aid packages disbursed by the Biden administration prohibited those particular funds from being used in that way).
Far be it from me to think that individuals who really are just a scourge on the rest of humanity be the ones to go first into the Russian meatgrinder, especially when you consider that they’re being handed all the perks of a functioning country without any of the sacrifice—in fact, not only are they not expected to earn any of those benefits, but they’re set to receive them...at the bloody expense of legitimate citizens.
(Seriously, do third world Islamic hordes provide any positive impact on the rest of the world? Not to be callous, but do they offer any value to anyone?)
Though, could they even be trusted on the front? Obviously that’s rhetorical, because of course not.
I know I’ve been quoting Pat Buchanan quite a bit in recent days, but his observations about the “seething racial resentment” from the third world and directed at the first is just so aproipos—but there’s also another application for it. The progressive left of the first world also possesses the exact same attitude, but it’s so much worse because the disdain is for their own people.
The legendary baseball player and manager Ted Williams once wrote a letter to the Angels outfielder Jay Johnstone on improving his hitting. Among his pieces of advice was that “with two strikes, you simply have to protect the plate.”
Williams’s advice on not striking out came to mind this week when another leak of confidential information rocked the Supreme Court. (The prior leak of the Dobbs decision went unsolved).
For Chief Justice John Roberts, the message is clear: it is a time like this when you have to protect the plate.
Roberts, of course, is famous for his own baseball analogies. In his confirmation, he declared that “judges are like umpires. Umpires don’t make the rules. They apply them…Nobody ever went to a ballgame to see the umpire.”
Yet, justices do make rules not only in new precedent, but in the operation of the court system. Those rules are being broken.
In the same week as the new leak, Justice Sonia Sotomayor attacked her colleague Brett Kavanaugh as essentially an out-of-touch prig who had never even met an hourly wage worker.
It was an unfair insult and a departure from the Court’s long-standing rules of civility.
(Sotomayor later apologized).
Additionally, a forthcoming book by Mollie Hemingway on Justice Samuel Alito contains an embarrassing account of how Justice Elena Kagan allegedly screamed at Justice Stephen Breyer so loudly before the Dobbs opinion that the “wall was shaking.”
(The book suggests that Kagan was upset with Breyer agreeing to spur along the dissents to get out the final opinions in light of rising threats against conservative colleagues after the leak).
For an institution that prides itself on its confidentiality and insularity, the Court is looking increasingly porous and partisan in these leaks.
Worse yet, people are indeed coming to the Court “to see the umpires.”
The most recent leak was published by the New York Times, which was given internal memos from various Supreme Court justices on the use of what is known as the “shadow docket” to issue rulings without oral arguments.
Notably, the leaks occurred after a controversial speech by Justice Ketanji Brown Jackson at Yale Law School in which she denounced the use of the shadow docket by her conservative colleagues to release decisions that were sometimes “utterly irrational.”
The memos reveal the concern of the justices that the Environmental Protection Agency was effectively gaming the system, imposing unlawful regulatory burdens on electric utilities despite a countervailing earlier ruling in Michigan v. EPA.
Chief Justice Roberts noted that the EPA was using the ongoing litigation to force utilities to spend billions of dollars to comply with the new regulations: “In other words the absence of stay allowed the agency to effectively implement an important program we held to be contrary to law.”
The controversy over the use of the shadow docket is immaterial to this story. The most immediate concern for Roberts should be that this is strike two: another leak from within the Court that was clearly designed to wound some of its members.
Unlike the Dobbs leak (which appeared to be an effort to influence the final opinion), this is a leak about a decade-old case. It had a purely malicious purpose to embarrass or disrupt the Court.
The question, again, is the identity of the culprit. There is no reason to assume that the same person was involved in both leaks. Rather, the leaks appear to reflect a deteriorating culture at the Court.
After the Dobbs leak, Chief Justice Roberts launched a fruitless investigation through the federal marshals to find the responsible person. The use of the marshals as the lead investigators (rather than the FBI) was criticized at the time. Roberts may have been sensitive to an executive-branch agency rooting around in the highest court of a sister branch.
The result was the worst possible outcome. The culprit succeeded in both leaking the opinion and evading any accountability.
The fact is that the Court’s culture and institutional identity have always been its greatest protection of confidentiality. In a city that floats on a rolling sea of leaks, the Court was an island of integrity and civility. The “umpires” could call balls and strikes without playing the leak game.
That culture is fast becoming nothing but a relic in the wake of yet another major leak. For the future of the Court and the faith of the public, Roberts has to set his reservations aside and bring in the FBI to find the culprit. Most importantly, he has to guarantee total transparency in allowing the public to see the results wherever they may lead. In other words, with two strikes, Roberts needs to protect the plate.
Agreat deal of national news coverage concerning Virginia has focused on the attempt by its new Democratic governor, Abigail Spanberger, and her confederates in the General Assembly to circumvent the commonwealth’s constitution in order to radically gerrymander the state’s congressional district map. This maneuver has, however, overshadowed another of their equally dubious legislative actions. A bill proposing that Virginia join the National Popular Vote Interstate Compact (NPVIC) passed both houses of the General Assembly in February, and Gov. Spanberger signed it into law on April 13.
The NPVIC is a scheme cooked up by the Democrats to avoid the inconvenience of winning presidential elections by garnering a majority of Electoral College votes. They have been selling this boondoggle as a way of neutralizing an “obsolete” institution that allegedly preserves an inequitable provision of the Constitution. In reality, NPVIC is just another effort to endow the heavily populated, Democrat-dominated regions of the country with even more political power than they already wield. Fortunately, it will fail. If you haven’t read the official NPVIC pitch, here’s what it would accomplish, according to its website:
The National Popular Vote Interstate Compact would guarantee the Presidency to the candidate who receives the most popular votes across all 50 states and the District of Columbia … Under the National Popular Vote Interstate Compact, no voter will have their vote cancelled out at the state-level because their choice differed from plurality sentiment in their state. Instead, every voter’s vote will be added directly, without distortion, into the national count for the candidate of their choice. This will ensure that every voter, in every state, will be politically relevant in every presidential election.
How would NPVIC achieve this miracle? There would be a formal agreement among various states controlling 270 or more presidential electors who would be required to cast their ballots for any candidate receiving the most popular votes across the country — even if some other candidate wins a majority in one or more of the member states. Thus far, 18 states and the District of Columbia have joined the movement, and a brief perusal of the current signatories to this compact will render its true objective all too clear. The National Conference of State Legislatures lists the states that have joined the NPVIC and the electoral votes they now control:
California (54), Colorado (10), Connecticut (7), Delaware (3), Hawaii (4), Illinois (19), Maine (4), Maryland (10), Massachusetts (11), Minnesota (10), New Jersey (14), New Mexico (5), New York (28), Oregon (8), Rhode Island (4), Vermont (3), Virginia (13), Washington (12), and the District of Columbia (3). With the addition of Virginia the member states collectively control 222 electors, 44 electoral votes short of 270 needed for NPVIC to “take effect.” Even if they eventually convince enough states to provide those final 44 electoral votes, the NPVIC will nevertheless run afoul of the U.S. Constitution. As Alexandra Orbuch explains in the Princeton Legal Journal,
By giving its member states powers that they otherwise would not have had, the NPV Interstate Compact meets the standard of unconstitutionality. It allocates electoral votes to the winner of the overall popular vote rather than just to the winner of the vote in their respective states and gives the signatory states more power than those who refuse to sign the bill. As discussed earlier, the states involved would effectively be silencing the rest of the country. And as we have seen, that means that the right wing of the country would lose its voice in elections and thereby in policy making.
This is precisely why the Constitution’s Compact Clause (Article I, Section 10, Clause 3) prohibits states from entering into any agreement or compact with another state without the consent of Congress. It is no coincidence that all of the states that have joined NPVIC are controlled by the Democrats. If the upcoming midterms go badly for the Republicans, some “purple states” could very well bestow governing trifectas to the Democratic Party. As Jason Willick points out in the Washington Post, “In Michigan [15 electoral votes] and Pennsylvania [19 electoral votes], just one house of the legislature would need to flip for Democrats to have a trifecta.”
There can be little doubt that they will follow Virginia’s example and join NPVIC. This would put them within 10 electoral votes of 270. In Nevada, Republican Gov. Joe Lombardo is up for reelection in November and the Silver State’s legislature is firmly in the grip of the Democrats. Nevada controls six electoral votes, so if Lombardo is unseated the Democrat trifecta would put NPVIC within four votes of the magic number. Then there are “unpredictable” states like Arizona and Wisconsin. If the Democrats gain Trifectas in either of these states, the proponents of NPVIC will have created a constitutional crisis that will have a profound effect on 2028.
It goes without saying that this would produce an avalanche of lawsuits from the states. The ensuing litigation would certainly result in a Supreme Court battle that would be far more explosive than Bush v. Gore, and the inevitable ruling against the signatories to NPVIC would result in a Democratic reaction that would make their 2016 and 2024 antics seem rational by comparison. All of this could be avoided if the Democrats were truly interested in popular sovereignty. NPVIC is about nothing more than shifting power to heavily populated, Democrat-controlled regions and the end goal is a one-party state over which they hold sway.
David Catron is a recovering health care consultant and frequent contributor toThe American Spectator.
