FDA announces voluntary recall of several medicines containing valsartan

FDA announces voluntary recall of several medicines containing valsartan

The Drug Regulatory Authority of Pakistan has stopped nine companies from producing and distributing a drug used to control blood pressure and prevent heart failure because it may cause cancer. N-nitrosodimethylamine (NDMA) was found in the recalled products.

The human carcinogen NDMA is an organic chemical that is also used to make liquid rocket fuel, softeners, and lubricants.

According to the FDA, the presence of NDMA is these drugs was unexpected.

The firms recalling products include Major Pharmaceuticals' Valsartan, Solco Healthcare's Valsartan and Valsartan/Hydrochlorothiazide (HCTZ), and Teva Pharmaceuticals Industries' Valsartan and Valsartan/Hydrochlorothiazide (HCTZ).

It is also a byproduct from pesticide manufacturing, or during the making of rubber tires or fish processing. The agency also recommends that consumers determine if they are taking a recalled product, find the company-specific recall instructions, and contact their pharmacy and physician. The impacted medications were supplied by Teva Pharmaceuticals, and include Valsartan 80mg tablets and Valsartan 160mg tablets with the expiration dates of July 2018, February 2019, or May 2019.

The FDA points out that not all products containing valsartan are being recalled.

Global economic expansion has hit plateau, warns International Monetary Fund
The rate of expansion appears to have peaked in some major economies and growth has become less synchronised, reads the outlook.

"The FDA's review is ongoing and has included investigating the levels of NDMA in the recalled products, assessing the possible effect on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company", the FDA said Friday in a news release.

In Europe, Novartis is recalling Sandoz' valsartan and valsartan HCT film-coated tablets in 23 countries.

FDA announced a voluntary recall of common heart drug with the active ingredient valsartan.

"The FDA is committed to maintaining our gold standard for safety and efficacy". The FDA said it is now investigating the levels of NDMA in the recalled products, assessing the effect on patients and working with Huahai to solve the problem in future batches. "That includes our efforts to ensure the quality of drugs and the safe manner in which they're manufactured", said FDA Commissioner Scott Gottlieb, M.D.

Patients are advised to talk to their doctor if they are taking the medication.

As swift as the FDA's response appears to be, the whole issue has re-ignited an important conversation regarding how the United States can ensure the safety of imported drugs in the future - especially as imported drugs become more and more common.

Related News:

  • Home Run Derby results today: Bryce Harper of Washington Nationals wins

    Home Run Derby results today: Bryce Harper of Washington Nationals wins

    Harper did end up winning the Home Run Derby in front of the home crowd at Nationals Park - edging Kyle Schwarber to do so. Not only did Harper pull off the win in front of his adoring fans, but he also did with his dad pitching to him.
    Lyon chairman reopens possibility of Nabil Fekir moving to Liverpool

    Lyon chairman reopens possibility of Nabil Fekir moving to Liverpool

    I think he is looking at two possibilities: "To stay to play the Champions League with us or to leave to join a bigger club". The Reds were close to signing the France worldwide in a big-money deal from the Ligue 1 side in the current transfer market.
    Karnataka lynching: Police arrest around 30, including WhatsApp group owner

    Karnataka lynching: Police arrest around 30, including WhatsApp group owner

    The group made a decision to stop for some refreshments at a shop near Balkut Tanda, where they came across some school children. He said 10 policemen, including himself, tried to form a ring around the victims, but the mob attacked them too.
  • Royals release new photos to mark Prince Louis's christening

    The family, including newlyweds Meghan Markle and Prince Harry , gathered for the private ceremony at the Chapel Royal at St. Kate wore a cream Alexander McQueen dress with floral headpiece by Jane Taylor, and her long hair was swept back in a bun.
    Putin summit underway in Helsinki amid protests

    Putin summit underway in Helsinki amid protests

    It was unclear if Senate or House of Representatives leaders would back such a move or how new sanctions might be crafted. Russian officials say Putin is expected to reiterate denials of meddling in the 2016 United States presidential campaign.

    United Kingdom parliament vote to reveal extent of anger over May's Brexit plan

    Johnson, warned Monday that the Brexit "dream is dying" and Britain is "headed for the status of colony" with May's plan to stay close to the EU.
  • Britain's Theresa May wins parliament vote after bowing to Brexit pressure

    Britain's Theresa May wins parliament vote after bowing to Brexit pressure

    More wobbles, after the high-profile resignations, could leave the prime minister in a very fragile position. MPs will vote on whether to start their summer recess on Thursday instead of next Tuesday .
    Roku's wireless speakers are just for its TVs

    Roku's wireless speakers are just for its TVs

    Roku on Monday announced it is getting into the speaker business with the introduction of the Roku TV Wireless Speakers . If you don't yet own a Roku Smart TV, oh, look at that, Amazon has two Prime Day deals on 2017 TCL Roku Smart TVs .
    Ex-minister calls for second Brexit vote

    Ex-minister calls for second Brexit vote

    Asked if any other senior Tories backed a second referendum, she said: "Yes I believe so". She told BBC Radio 4's Today she would campaign for Remain in any new vote.
  • Theresa May Rejects Idea of Second Brexit Referendum

    She said that would remove Britain's ability to have an independent trade policy and her government "will never stand for that". She joined fellow Tory rebel Phillip Lee, who resigned as a justice minister to oppose the Government on Brexit.
    May says Trump told her to sue the EU over Brexit

    May says Trump told her to sue the EU over Brexit

    Former education secretary Justine Greening said other senior Conservatives quietly back a second Brexit referendum. Asked by Piers whether they had discussed Brexit, the President replied: "I did".
    Baby died from drug overdose after drinking mother's breast milk

    Baby died from drug overdose after drinking mother's breast milk

    She told police officers, per the affidavit, that she had been prescribed methadone because of an addiction to painkillers. Police arrived at the home in New Britain, about 35 miles north of Philadelphia , to find the baby in cardiac arrest.

Most liked

Ghost 'Neutrinos' Particles: Earth-Targeting Cosmic Rays Confirmed In New Report
Blazars are thought to generate neutrinos and gamma rays, possibly explaining at least one source of cosmic rays . This particular galaxy type is known as a blazar , because one of the jets is trained directly towards Earth.

Sacha Baron Cohen Tricks Politicians in New Showtime Series
Walsh added in a tweet on Sunday, "no, I don't believe we should train & arm kindergarteners". "Stolen Valor" scolds Sabo in both. Ruddick is the same character Baron Cohen adopted while speaking with Palin, for a segment that has yet to air.

Donald Trump denies collusion, says Russian Federation probe 'a disaster' for US
There was a lot up in the air going into Monday's talks, but the ongoing Russian Federation investigation loomed front and center. We've all been foolish", he said, before veering into a discussion about his election victory.

British police find ‘small bottle’ of Novichok in victim’s home
The force also said searches are expected to continue "for several weeks, if not months". The discovery of the bottle leaves Metropolitan Police with more questions than answers.

'WHO NEEDS LABELS': Paris Jackson reveals she's bisexual
The 20-year-old actress and model opened up about her sexuality when she was just 14, but some sites are just catching on now. Her confession about her sexuality comes not long after Jackson's grandfather, Joe Jackson, passed away.

Eight rhinos die after move to a new park in Kenya
Eight of the critically endangered animals died after being moved to a national park. They said the rhinos died of salt poisoning after drinking water in their new home.

Arsenal boss Emery ordered players back to training during friendly win
Mesut Ozil will travel with Arsenal for their pre-season tour of Singapore, new head coach Unai Emery has confirmed. And for me that's very important, because he helps every day on the pitch, he helps every day in the dressing room.

Prime Day 2018: How to get the best deals, starting Monday
It designed the day to replicate Black Friday for Amazon die-hards, but boasted more deals than the November shopping tradition. Based on its data, Prime Day was the biggest online shopping day in the third quarter across several categories.

Helsinki Summit: Trump Introduces First Lady Melania to Putin
Image copyright Reuters Image caption Protesters in Finland have been urging Mr Trump to focus on human rights ahead of his visit. The drama between Trump and Putin will play out at the imposing 19th Century presidential palace in Helsinki from about 6:00 a.m.

CVS apologizes after managers call cops on black customer
An "assault in progress" was called in from at least one of the two calls made from the store at the time, according to Buzzfeed . It all went down when Camilla Hudson tried to use a coupon that CVS manager Morry Matson didn't recognize.

Gerry Adams' house in Belfast is attacked
Former Sinn Fein president Gerry Adams has called on those who attacked his home to meet him and explain why they did it. Adams tweeted that no one was injured in the attack on his home, but that a vehicle in his driveway had been damaged.

DC United top Whitecaps in Rooney's debut
With time winding down and Vancouver about to be shut out, Davies put on a show while scoring his third goal of the season. Rooney fired a risky header in the 79th minute that was fisted away by Vancouver goaltender Brian Rowe. "They were great.

UK's Theresa May: Trump told me to 'sue the EU' over Brexit
Britain's plans to leave the European Union bloc have been slowed by difficulty reaching an exit deal with European Union leaders. May has said there could be "no Brexit at all" if the country doesn't keep it's "eyes on the prize ". "But I liked her a lot".

Nathan Fillion has released an "Uncharted" fan film
Last week, nerd-favourite actor Nathan Fillion made a winking reference to Uncharted on social media. Check it out via the director's YouTube channel.

NASA Image Shows Martian 'Spiders' Emerging for Spring
Rather, these are marks on the land called " araneiform terrain ", a type of mound that appears to radiate outward with tendrils. The image shows a carbon ice cap that enveloped the region during the winter as the sun returns in the spring.