Over 140,000 bottles of atorvastatin recalled in US over quality concerns
NEED FOR A NEW MECHANISM: This incident underscores the importance of rigorous post-market surveillance for quality control and the need for establishment of a foolproof communication channel between regulators, manufacturers, distributors, sellers and the public, which may also serve as a platform to watch out for fakes. Meanwhile, patients under any treatment are always advised to stay informed and be in constant touch with the medical staff.
BEDMINSTER (New Jersey), Nov 3: The No. 1-selling drug in the US is being recalled—atorvastatin
calcium tablets. In a sweeping move that has sent ripples across the US healthcare
landscape, the Food and Drug Administration (FDA) has announced a nationwide
recall of over 140,000 bottles of atorvastatin calcium tablets, the generic
form of the country’s top-selling cholesterol-lowering medication, otherwise
called statins.
According to the FDA, the affected batches failed to meet dissolution specifications,
meaning the tablets may not break down properly in the body, potentially compromising
their effectiveness.
The recalled atorvastatin calcium tablets is what Ascend Laboratories distributed
nationwide in the US and manufactured by Alkem Laboratories Ltd., based in India.
Ascend is a distributor, not a manufacturer, headquartered in New Jersey. Ascend
being the distributor is involved in executing the recall but FDA typically
holds the manufacturer responsible for production flaws.
According to the US Food and Drug Administration, Ascend Laboratories, out
of New Jersey, initiated a voluntary recall for more than 140,000 bottles of
its atorvastatin calcium tablets. The recall includes bottles of the company’s
10 milligram, 20 milligram, 40 milligram and 80 milligram tablets in 90-pill
count bottles. Each bottle contained 90, 500 or 1,000 tablets, for three, 17
or 33 patients, respectively, for one month.
The recall, initiated in late October 2025, affects multiple dosages and lot
numbers of the drug, which is prescribed to more than 29 million Americans annually,
with over 115 million prescriptions written each year. The generic atorvastatin
is also available under the original brand name Lipitor sold by Pfizer. The
statin is widely used to lower cholesterol and reduce the risk of heart disease.
The batches made from November 2024 till September 2025 had the defect.
Advisory to patients
While no adverse events have been reported so far, the agency emphasized that
patients should not stop taking their medication abruptly. Instead, they are
urged to check their prescription bottles for matching lot numbers and consult
their healthcare provider or pharmacist for guidance.
The recall has reignited concerns over quality control in overseas pharmaceutical
manufacturing as well, as many generic drugs are produced outside the US. Industry
analysts suggest the issue may stem from lapses in production oversight.
Healthcare professionals are now working to ensure continuity of care for affected
patients. Pharmacies nationwide have begun notifying customers and offering
replacement prescriptions where necessary. Experts stress that while the recall
is serious, it does not indicate a widespread safety issue with atorvastatin
itself.
Alternatives to recalled generic atorvastatin
Patients should not switch medications without consulting their doctor. Alternatives
exist, but individual tolerance, insurance coverage and clinical history matter.
The recall affects specific batches of generic atorvastatin distributed by Ascend
Laboratories only, not the entire class of statins or their brands. Ascend Laboratories
is not making or selling Lipitor.
Alternative 1, Lipitor: The original brand name of statin developed
and sold by Pfizer. It is not affected by the current recall and remains a trusted
option for cholesterol management. Lipitor became the best-selling drug in history,
generating over $130 billion in global sales before its patent expired in 2011.
Pfizer developed and launched Lipitor (atorvastatin calcium) in 1997. As the
patent for the medicine Pfizer developed expired in 2011 others too are producing
the generic medicine. But Pfizer owns the Lipitor brand name and Lipitor remains
a Pfizer trademark. So all Lipitor is Pfizer, even if production is outsourced.
Pfizer may produce Lipitor in its own facilities or contract out manufacturing
to other companies, including overseas plants and Pfizer packages and sells
them under the Lipitor name and has to take the responsibility for quality.
Therefore the story is: After the patent expired, generic versions of atorvastatin
produced by others flooded the market, but Pfizer retained exclusive rights
to the Lipitor brand name and trade mark. Lipitor is not affected by recall.
Alternative 2, Rosuvastatin calcium: It is another statin, sold under
the brand name Crestor (by AstraZeneca) and also available in generic form.
It works similarly to atorvastatin but may be preferred in certain clinical
scenarios due to its potency and pharmacokinetics.
What is Class II recall: The FDA gave the recall a Class II status,
which means that the medication could cause “temporary or medically reversible
adverse health consequences.”
Dissolution specifications: When swallowed a medicine should dissolve
so that the active ingredient in it can be absorbed by the body. It then goes
to the liver. Here atorvastatin reduces the low-density lipoproteins called
LDL or “bad cholesterol” in the blood. In the recall case, sample pills failed
to dissolve properly. Lower LDL reduces cardiovascular events like heart attacks
and strokes.—Agencies
The CCTV footage and the video circulating on social media do not indicate any serious abnormalities in takeoff or descent, it has been confirmed. The disaster is becoming curiouser and curiouser. The flight path was not curvy. And the aircraft maintained a steady, gliding descent with its nose straight and the wings perfectly level. The pilot's distress call does not specify what prevented lift and climb-out. Here are some expert opinions. The sole purpose is to raise travellers' awareness about air travel.
Many of the victims were charred beyond recognition, making identification difficult. Three hundred nineteen body parts have been sent for DNA matching with relatives to determine the identities.
A comment on social media on Kanimozhi's answer on the question of national language read: "Daughter of Kalaignar M. Karunanidhi. Delivered the Birthday Present to her Father!!" (Karunanidhi was born on June 3, 1924)
(Today's headlines )
Trump said, "Elon is not really leaving" and will be "back and forth" to the White House because DOGE is his "baby." "I think he’s going to be doing a lot of things.”
Musk wrote: "My scheduled time as a Special Government Employee comes to an end... The @DOGE mission will only strengthen over time as it becomes a way of life throughout the government." Now on it will be on auto-pilot.
PROGNOSIS: DOGE was prematurely born to protect the country by aborting an impending socio-economic disaster which very few people could see coming.
Although its immediate job was to save American taxpayers billions by slashing waste, eliminating fraud, cutting Government bloat and ensuring utmost efficiency in administration for the good of the people.
(Today's headlines )
"Coming from a system like in England, empowering," she says she never had an idea of this sort of experience... being asked to “socialise with middle-aged men” who financed the event...humiliating...
Originally from Junagadh, Gujarat, Pataudi was relocated to Etawah Lion Safari in September 2019 before being transferred to Gorakhpur Zoo in 2021. Recently it was receiving treatment for pancreatic and liver infections. After tigress Shakti died in the zoo on May 7 due to bird flu, Pataudi was shifted to Kanpur. Some birds are also reported to have died mysteriously around Gorakhpur. All zoos in UP are closed for fear of a bird flu outbreak.
Three other animals too had died - a tiger, a leopardess and a female wolf. Wolf Bhairavi died last Saturday, leopardess Mona died the Thursday before that and tiger Kesari died on March 30. Some of them had Shakti's symptoms but the cause of death has not been confirmed yet.
As tourist inflow is an indicator of normalcy returning to an erstwhile terrorist infested Valley, the Government has been trying hard to make everything travel-friendly, launching lot many projects and bringing Kashmir on the national rail map that physically completes the process of Kashmir's integration with the rest of India. And that defeats the designs of Pakistan eyeing Kashmir and simply explains a recrudescence of terrorism in J&K.
"It's a big victory not just for Tamil Nadu but for all Indian States. DMK will continue to struggle for and win State autonomy and Federal polity," Chief Minister MK Stalin said.
Of 2.08 km in length, it features 99 spans and a 72.5-metre vertical lift span that rises up to a height of 17 metres, facilitating smooth movement of ships while ensuring seamless train services to the holy town of Rameswaram on Pamban island.
ANALYSIS: There is a lot of hue and cry around the world over Trump's tariffs. But tariff, simply put, is a tax. But unlike tax, it affects the exporting country too. Domestic prices will go up for some time. Nothing more will happen, good or bad!
What motivated Trump's newfound policy, apart from being a stunt to justify his existence in the White House, is a false realisation that increased tariff will make foreign goods prohibitive, thereby boosting local production, and create more jobs, and more prosperity will ring in! If that is true, India would have been shining by now: Producing own Rolls-Royce La Rose Noire Droptail and Scotch Whiskies! And what about coconut and palm oil by America!
(Today's headlines )
PROGNOSIS: It looks a Real New Trump is emerging - courageous, balanced, powerful and disinterested. Determined to save his country from the cliff, he has done quite a few draconian things that will reduce the burden of debts of the Federal entity, like the golden handshake, stopping senseless funding, pulling out of a worthless WHO. Shutting the Education Department is another. On the other hand, running it is also not the Centre's job either (We will convincingly elaborate it in the next chapter).
In India the scene is just the opposite. Centralisation is the core agenda and identity of the ruling dispensation without which it has no existence, or in other words, it exists for that set of schemes only. A realisation of this never dawned upon any Opposition party in 2014 or any time thereafter, what to talk of being able to see it coming 70 years ago! The consequence of all this violation of basic natural law of the universe we cannot predict.
THE AMERICAN CONUNDRUM: Political venom has migrated to top echelons in the US. It was reported last year NASA has become politicised, vitiated. But NASA refuted the charge. How Boeing developed a glitch but its unmanned return was smooth. When Suni-Wilmore were stranded last June, why the return was set for February? Because that comes only after January 20! SpaceX called the shots, for itself and for Trump. Then the mission was manipulated for March for a better bargain! In between, what made Elon Musk 'predict' during campaign if Kamala Harris wins he would be in jail. In politics, it is said, "the only rule is there are no rules." Difficult times for Americans too.
The terminations are part of a large-scale exercise going on all across Fed departments and organisations to reduce wasteful Government expenditure as decided by a Trump in a mess gone berserk, and improve administrative efficiency following the whims of billionaire and his associate Elon MusK and his DOGE. It has not been shared how terminations are going to raise the efficiency bar! It looks like Trump has stolen some of the prescriptions meant for India. But the American problems are quite different.
Suddenly these colonial clerks feel this effortless, little rule will tremendously enhance security and convenience for the railway passengers manifold. More stations will be covered in the next 77 years! (Also See:
New Delhi station stampede... What went wrong?)
ANALYSIS: "The standard operating procedure for deportations by aircraft used by ICE that is effective from 2012 provides for the use of restraints," says the Government. That means, it is taken for granted the US will set the standard for deportations. For another, the Government is more interested in comparing with what happened in 2012 under a different Government to justify its own compliance! No surprise, others are trampling upon us. (How we conduct ourselves inside decides, inherently, how we are treated outside) Thirdly, the Government blamed the gangs doing the business of human trafficking for the illegal migration. For all the crimes taking place in the country, let us blame the criminals! Funny! We will never move an inch forward! The mindset defines what we are.
Meanwhile, a UN-returned Congress leader Shashi Tharoor sounded like a layman when he said, "If they are citizens of India we have an obligation to take them back." Who said 'No'?. He should know that is not the issue now. Who will identify an undocumented person, and how?
OPINION: A nutty 'new' Trump must know checking illegal immigration is his job and not theirs. And 'penalty' tariff is not a solution. However, Trump talking about "major threat" from "illegal aliens" (illegal immigration) is about what he believes, right or wrong, and to that extent he is genuine and honest; it is certainly not a pretension to prop up his political relevance. Bullies are always true to themselves. Look at India's crooked politicians shouting day in, day out to prove they are more patriotic, and to whip up public sentiments for them to ride on!
The function was held indoors from 12 pm (10:30 pm IST) at the rotunda of the US Capitol building because of unusually intense cold and snow. Delivering his inaugural address, Trump remarked, “The golden age of America begins right now," and just hours later signed a slew of executive orders to redeem the election pledges.
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