Sun Pharma, Lupin, Dr Reddy's recall products in US market due to manufacturing issues
Sun Pharma
,
Lupin
and
Dr Reddy's Laboratories
are recalling drugs in the
US market
due to manufacturing issues and product mix up, according to the
US health regulator
.
As per the latest Enforcement Report of
US Food and Drug Administration
(
USFDA),
), the Mumbai-headquartered
Sun Pharmaceutical Industries
is recalling 5,448 bottles of a generic medication in the US.
Explore courses from Top Institutes in
Please select course:
Select a Course Category
PGDM
Operations Management
MBA
others
Data Analytics
Cybersecurity
Public Policy
Management
Healthcare
Design Thinking
MCA
Data Science
Data Science
Product Management
Others
Artificial Intelligence
Degree
Project Management
Digital Marketing
Technology
Leadership
CXO
healthcare
Finance
Skills you'll gain:
Financial Analysis & Decision Making
Quantitative & Analytical Skills
Organizational Management & Leadership
Innovation & Entrepreneurship
Duration:
24 Months
IMI Delhi
Post Graduate Diploma in Management (Online)
Starts on
Sep 1, 2024
Get Details
Princeton-based Sun Pharmaceutical Industries Inc is recalling the affected lot of Lisdexamfetamine Dimesylate capsules (60 mg) due to "Failed Dissolution Specifications", the US health regulator stated.
by Taboola
by Taboola
Sponsored Links
Sponsored Links
Promoted Links
Promoted Links
You May Like
How Much Does It Cost to Rent a Private Jet - The Prices May Surprise You!
Private Jet I Search Ads
Learn More
Undo
The medication is used to treat attention deficit hyperactivity disorder (
ADHD
).
The drug firm initiated the Class II recall in the US on June 16 this year, it added.
Live Events
Another Mumbai-based drug maker Lupin is recalling 58,968 bottles of a generic combination medication used to treat high blood pressure.
Naples-based Lupin Pharmaceuticals Inc is recalling Lisinopril and Hydrochlorothiazide tablets (USP 20mg/12.5mg). The affected lot was manufactured at the company's Nagpur-based manufacturing facility.
As per the USFDA, the company initiated the Class II recall on June 20 due to "Product Mix Up".
This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg, the US health regulator stated.
In another filing, the US health regulator said that
Dr Reddy
's Laboratories is recalling 1,476 bottles of Omeprazole Delayed-release capsules.
The medication is used to treat certain stomach and esophagus problems.
Princeton-based
Dr. Reddy's Laboratories
, Inc initiated the Class II recall on June 30, 2025, USFDA stated.
The affected lot was produced at the company's Bachupally (Telangana)-based manufacturing facility.
The recall is due to the presence of foreign tablets/capsules, USFDA said.
It is due to the presence of foreign Divalproex Sodium extended-release 250mg tablets in a bottle of omeprazole capsules, it added.
As per the USFDA, a Class-II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Time of India
an hour ago
- Time of India
What is CTE? Why this brain disease is behind Manhattan shooting by Shane Tamura
Manhattan shooter Shane Tamura blamed football for his brain disease CTE. Shane Tamura, the crazed gunman who killed five people inside a Midtown skyscraper that housed many offices, mentioned CTE several times in his long manifesto, which can also be read as a suicide not,e as he ended his life after killing people in the office. CTE is Chronic Traumatic Encephalopathy, which is a degenerative brain disease caused by repeated head trauma, such as concussions or even sub-concussive hits (blows that don't cause symptoms but still jolt the brain). Football players, boxers, hockey players, military veterans are often diagnosed with this disease. Tamura claimed that he was suffering from CTE and blamed football for his condition. New York Post reported that in his note, he thanked a documentary on CTE brain injuries and listed the names of several prominent neuroscientists. 'Terry Long, football gave me CTE and it caused me to drink a gallon of antifreeze,' Tamura wrote. 'You can't go against the NFL, they'll squash you.' 'Please study brain for CTE. I'm sorry. The league knowingly concealed the dangers to our brains to maximize profits. They failed us," he wrote. In CTE (Chronic Traumatic Encephalopathy), the brain deteriorates over time due to repeated hits to the head—even if those hits don't cause a full concussion. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Treatment That Might Help You Against Knee Pain Knee pain | search ads Find Now Undo CTE is rare and not completely understood by doctors, and there is no way to diagnose the disease in a living person – doctors can only confirm the disease in an autopsy after death. The disease has been linked to football, given the contact-heavy, physical nature of the sport. The note mentioned 'Fainaru brothers' — the two ESPN reporters who co-wrote the 'League of Denial' book. Elsewhere, the names of several doctors were featured on one page, including Dr. Ann McKee, the chief of neuropathology at BU Alzheimer's Disease Research Center, and Dr. Christopher Nowinski, the co-founder of Boston University's CTE Center. Tamura has been described as a mentally unstable person but there is no history of him professionally playing football. But it is believed that his apparent target was the NFL office, which was at the same building but he did not kill anyone from NFL and ended up killing Wesley LePatner, an executive of Blackstone. Tamura worked as a security guard at a Las Vegas casino and he did not report to duty Sunday. He drove through several states to reach New York City just hours before the mass shooting. Tamura's car was spotted passing through Colorado on July 26, Nebraska and Iowa on July 27, and Columbia, New Jersey, at 4:24 p.m. Monday. And then he drove into Manhattan. Cops found a rifle case with rounds, a loaded revolver, extra ammunition, magazines, a backpack and medication prescribed to him searching his car. He had a concealed firearms permit from Las Vegas with a 2027 expiration date. CTE and football A 2017 study by Boston University's CTE Center found that of the 111 NFL brains it examined, 110 had some level of CTE. In September 2024, a study by the Football Players Health Study at Harvard University revealed that out of a sample of 2,000 former NFL players, about a third believed they have CTE.
Time of India
an hour ago
- Time of India
Trump acknowledges "real starvation" in Gaza, vows to increase food aid
US President Donald Trump has acknowledged the severe hunger crisis in Gaza after months of largely deflecting questions on the issue, stating that the United States would increase food aid to the war-hit enclave, The New York Times reported. During a 75-minute press session with UK Prime Minister Keir Starmer in Scotland on Monday, Trump pledged to "set up food centers" in Gaza, although he offered no specifics on how aid would reach the enclave that has faced more than 20 months of Israeli bombardment and aid restrictions. Explore courses from Top Institutes in Please select course: Select a Course Category Healthcare Degree healthcare Public Policy Finance Data Science MBA Artificial Intelligence Leadership Technology Data Science Others Management Product Management Cybersecurity Project Management MCA others CXO Operations Management Skills you'll gain: Financial Analysis in Healthcare Financial Management & Investing Strategic Management in Healthcare Process Design & Analysis Financial Analysis in Healthcare Financial Management & Investing Strategic Management in Healthcare Process Design & Analysis Duration: 12 Weeks Indian School of Business Certificate Program in Healthcare Management Starts on Jun 13, 2024 Get Details Skills you'll gain: Financial Analysis in Healthcare Financial Management & Investing Strategic Management in Healthcare Process Design & Analysis Duration: 12 Weeks Indian School of Business Certificate Program in Healthcare Management Starts on Jun 13, 2024 Get Details "We're giving money and things," Trump said, adding, "I want to make sure they get the food, every ounce of food." by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like 10 Signs Your Dog Loves You More Than Anything Liseer Read More According to The New York Times, Trump's shift in tone came after meetings with several European leaders, including European Commission President Ursula von der Leyen and Starmer, who reportedly spoke of a "sense of revulsion" at the suffering in Gaza. "That's real starvation stuff, I see it, and you can't fake that," Trump said. "We have to get the kids fed." Live Events At least 56 Palestinians died from starvation this month alone, nearly half of the total deaths from hunger since the war began 22 months ago, the Gaza Health Ministry stated on Saturday. International agencies and medical experts have repeatedly warned that a famine is sweeping through the region due to Israel's tight restrictions on food and medicine. Earlier, Trump had drawn criticism for downplaying the humanitarian catastrophe, reportedly complaining that the United States had not received gratitude for the aid already provided. "Nobody said, 'Gee, thank you very much,'" Trump remarked on Sunday. "And it would be nice to have at least a thank you." During a meeting with von der Leyen, he called the crisis "not a U.S. problem, it's an international problem," while reiterating frustrations over a lack of recognition for America's contributions. The New York Times noted that his administration recently approved $30 million in funding for an Israeli-backed aid system in Gaza run mostly by American contractors. However, Trump's remarks on Monday marked a notable departure from his recent stance, as he criticised the existing distribution mechanisms and called for more accessible aid delivery. "We're going to set up food centers and where people can walk in and no boundaries. We're not going to have fences," he said. "They see the food. It's all there, but nobody's at it because they have fences set up that nobody can even get it. It's crazy what's going on over there." He added that Britain would support the United States in the new aid push. Trump also appeared to distance himself from Israeli Prime Minister Benjamin Netanyahu's recent claims that there was no starvation in Gaza. "I don't particularly agree with that, Trump said, adding, "The children look very hungry." Despite Trump's assertion that "no other nation gave money," The New York Times reported that the European Union had spent approximately $605 million on Gaza aid since 2023, according to the European Commission. The hunger crisis in Gaza has become one of the worst humanitarian emergencies in recent memory, with over two million Palestinians living amid widespread destruction and shortages of essential supplies. Trump's remarks have raised questions about whether his "America First" foreign policy can adapt to a crisis that demands multilateral humanitarian leadership, the New York Times noted.
Time of India
an hour ago
- Time of India
What is Leqembi? The first Alzheimer's treatment approved today in Saudi Arabia
Leqembi targets beta-amyloid plaques in the brain, aiming to slow Alzheimer's progression in patients with mild cognitive impairment The Saudi Food and Drug Authority (SFDA) announced today the official approval of Leqembi, the first Alzheimer's treatment available in Saudi Arabia. This approval marks a significant milestone in addressing Alzheimer's, a progressive brain disorder that affects memory and thinking skills. Leqembi is specifically indicated for patients experiencing mild cognitive impairment or mild dementia caused by Alzheimer's, who have either no copies or just one copy of a particular gene variant known as apolipoprotein E4 (ApoE4). How Leqembi Works: Targeting the Root Cause Leqembi represents an innovative approach to treating Alzheimer's. Unlike many existing therapies that only ease symptoms, this drug aims to slow the actual progression of the disease. It is a biologic therapy developed using monoclonal antibody technology, a sophisticated method that creates lab-produced molecules designed to target specific proteins in the body. In this case, Leqembi works by targeting beta-amyloid proteins, which tend to build up in the brains of Alzheimer's patients and form sticky clumps called plaques. These plaques are widely believed to contribute to the cognitive decline seen in the disease. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Patrocinio: Unsold Furniture Liquidation 2024 (Prices May Surprise You) Unsold Furniture | Search Ads Learn More Undo Specifically, brain plaques, known as amyloid plaques, are abnormal clumps of protein fragments called beta-amyloid that build up in the brain, especially in people with Alzheimer's. These plaques interfere with the normal communication between nerve cells (neurons), disrupting brain function. By helping reduce the formation of these harmful plaques, Leqembi seeks to protect brain function and slow cognitive decline over time. The treatment is given through an intravenous infusion every two weeks, allowing the drug to circulate and act within the brain. Proven Effectiveness Backed by Clinical Studies Before approving Leqembi, the SFDA thoroughly reviewed evidence of its safety, effectiveness, quality, and compliance with regulatory standards. Clinical trials revealed that Leqembi significantly slows the progression of Alzheimer's disease compared to a placebo. The effectiveness was measured using established clinical scales that assess memory, thinking, and daily functioning abilities. However, like all medications, Leqembi can cause side effects. The most commonly reported include: Headaches Reactions related to the infusion process Amyloid-related imaging abnormalities (ARIA), a term that refers to unusual changes detected in brain MRI scans. These abnormalities may include swelling (cerebral edema) or tiny brain bleeds (microhemorrhages). Because ARIA can only be detected through brain scans, careful monitoring is essential throughout treatment. Safety First: The Need for Careful Patient Monitoring The SFDA stresses the importance of ongoing patient monitoring during treatment. Before starting Leqembi, patients must be tested for their ApoE4 gene status, as this influences the risk of side effects. Those with two copies of the ApoE4 gene are not currently eligible for the treatment due to a higher likelihood of complications. Additionally, the pharmaceutical company responsible for Leqembi is required to track how the drug performs once it is in use (post-marketing surveillance). They must regularly submit updated reports on safety and effectiveness to the SFDA. A comprehensive risk management plan is also mandatory to ensure the treatment is used safely and responsibly. Advancing Healthcare with Biotechnology in Saudi Arabia The approval of Leqembi reflects the SFDA's commitment to expanding access to advanced and high-quality medical treatments, especially those developed through cutting-edge biotechnological methods. Biotech therapies like Leqembi represent a rapidly growing field in medicine, offering new hope for diseases that previously had limited treatment options. About the SFDA Established in 2003 under the Council of Ministers' resolution, the Saudi Food and Drug Authority is an independent regulatory body directly reporting to the President of the Council of Ministers. Its main mission is to safeguard public health by ensuring the safety and quality of food, medicines, biological and chemical substances, medical devices, and cosmetics. The SFDA oversees all procedures related to these products, aiming to protect both human and animal health throughout the Kingdom.
