J&J recalls 33,000 bottles of baby powder as FDA finds asbestos in sample

Johnson & Johnson said on Friday it is recalling around 33,000 bottles of baby powder in the United States after US health regulators found trace amounts of asbestos in samples taken from a bottle purchased online.

J&J shares fell more than 6 percent to close at $127.70.

The move marks the first time the company has recalled its iconic baby powder for possible asbestos contamination, and the first time US regulators have announced a finding of asbestos in the product. Asbestos is a known carcinogen that has been linked to deadly mesothelioma.

The recall is the latest blow to the more than 130-year-old US healthcare conglomerate that is facing thousands of lawsuits over a variety of products, including baby powder, opioids, medical devices and the antipsychotic Risperdal.

A jury last week ordered the company to pay $8 billion to a plaintiff in a case claiming J&J downplayed the risks of Risperdal. That award is not expected to stand, the company and legal experts have said.

J&J faces more than 15,000 lawsuits from consumers claiming its talc products, including Johnson's Baby Powder, caused their cancer.

On a conference call with reporters on Friday, Dr. Susan Nicholson, head of Women’s Health in the company's medical safety organization, called the asbestos finding "extremely unusual," adding that it was "inconsistent with our testing to date."

The voluntary recall announced on Friday is limited to one lot of Johnson's Baby Powder produced and shipped in the United States in 2018, the company said. 

J&J in a news release said that testing by the US Food and Drug Administration as recently as a month ago found no asbestos in their talc.

The FDA said in a statement that the latest sampling took place during its testing for asbestos in talc-containing cosmetics that it began reporting this year. A second Johnson’s Baby Powder sample from a different lot tested negative for asbestos, the agency said.

The FDA said it stands by the quality of its testing and results and recommended consumers stop using the product if it comes from the affected lot.

J&J said on the conference call that it received a report from the FDA on Oct. 17 alerting the company about the asbestos finding. It said it has started an investigation and is reviewing manufacturing records and collecting data on the distribution of the lot to determine where the product was shipped.

J&J added that it is working with the FDA to determine the integrity of the tested sample as well as the validity of test results.

THOROUGH INVESTIGATION NEEDED

The type of asbestos discovered by FDA testing has not been found in the mine where the company sources its talc, J&J's Nicholson said. She described it as an environmental contaminant most commonly found in building materials and industrial applications.

J&J said it was too early to confirm whether cross-contamination of the sample had caused a false positive, whether the sample was taken from a bottle with an intact seal or whether it was prepared in a controlled environment. It added that it could not confirm whether the tested product was authentic or counterfeit.

"It is so critical that we perform a thorough investigation of the sample to determine the source of contamination," Nicholson said.

Since 2003, talc in Johnson's Baby Powder sold in the United States has come from China through supplier Imerys Talc America, a unit of Paris-based Imerys SA and a co-defendant in much of the talc litigation. Imerys and J&J said the Chinese talc is safe.

J&J has known for decades that asbestos lurked in its talc, Reuters reported last year. Internal company records, trial testimony and other evidence show that from at least 1971 to the early 2000s, the company’s raw talc and finished powders sometimes tested positive for small amounts of asbestos. Company executives, mine managers, scientists, doctors and lawyers fretted over the problem and how to address it, while failing to disclose it to regulators or the public, Reuters found.

J&J has repeatedly said that its talc products are safe, and that decades of studies have shown them to be asbestos-free and that they do not cause cancer.

The FDA test indicated the presence of no greater than 0.00002 percent of chrysotile asbestos in the tested sample, J&J said.

The World Health Organization and other authorities recognize no safe level of exposure to asbestos. While most people exposed never develop cancer, for some, even small amounts of asbestos are enough to trigger the disease years later.

Thousands of the lawsuits against J&J have been consolidated before a New Jersey federal judge, who is currently weighing company motions to disqualify plaintiffs’ expert witnesses, including the head of an asbestos testing lab who has testified in earlier trials that he found the contaminant in J&J powders.

Leigh O’Dell, one of the lead plaintiff attorneys, on Friday said the recall "vindicates the position we’ve been taking for months.”

Wells Fargo analyst Larry Biegelsen said in a research note that the recall could encourage additional lawsuits and prompt the company to pursue a broader settlement.

Jefferies healthcare strategist Jared Holz said J&J has already lost close to $10 billion in market value due to the talc issue over the past year.

He said further downside to J&J stock is likely to be limited because legal concerns over talc are well known and have already taken a toll on the share price. "This is one single bottle within one lot with barely a trace here," he said.

J&J said in February that it had received subpoenas from the US Justice Department and the Securities and Exchange Commission for documents related to the asbestos contamination allegations. A Bloomberg report, which Reuters has confirmed, said those inquiries include a criminal grand jury investigation into how forthright J&J has been in its statements about the safety of its powders.

While talc products make up less than 1 percent of J&J sales expected by analysts to reach $82 billion in 2019, the New Jersey-based healthcare-products maker considers its Baby Powder to be an essential facet of a carefully tended image as a caring company.

source: news.abs-cbn.com

GSK recalls popular heartburn drug Zantac globally after cancer scare

GlaxoSmithKline on Tuesday said it was recalling the popular heartburn medicine Zantac in all markets as a "precaution", days after the US Food and Drug Administration found "unacceptable" levels of probable cancer-causing impurity in the drug.

Zantac, also sold generically as ranitidine, is the latest drug in which cancer-causing impurities have been found. Regulators have been recalling some blood pressure and heart failure medicines since last year.

Britain's medicines watchdog said GlaxoSmithKline (GSK) was recalling four prescription-only Zantac medicines: a syrup, an injection and tablets of 150 and 300 milligram (mg) dosages.

Over-the-counter 75 mg dosage Zantac products are produced by a different company and are not affected by the recall, it added.

"GSK informed the MHRA of our decision to suspend the release, distribution and supply of all dose forms of Zantac products," a company spokesman confirmed to Reuters.

"GSK is continuing with investigations into the potential source of the NDMA," he said, adding that the investigations include continued engagement with its suppliers and with external laboratories to conduct tests on finished product batches of Zantac.

The Medicines and Healthcare products Regulatory Agency (MHRA) said healthcare professionals were told on Monday to "stop supplying the products immediately, quarantine all remaining stock and return it to their supplier".

"We are advising that patients should not to stop taking their medication, and do not need to see their doctor until their next routine appointment but should seek their doctor's advice if they have any concerns," the MHRA said.

GLOBAL STOPPAGE

US and European health regulators said last month they were reviewing the safety of ranitidine, after online pharmacy Valisure flagged the impurities.

The FDA said Valisure's higher-temperature testing method generated very high levels of NDMA from the ranitidine drugs.

NDMA had previously been found in some blood pressure medicines from a class of drugs known as angiotensin II receptor blockers, or ARBs.

After checking the over-the-counter drugs using a low-heat method of testing, the FDA said it found much lower levels of NDMA than was discovered with a higher temperature test employed by Valisure.

The US regulator has asked ranitidine makers to conduct their own testing to assess levels of the impurity and to send samples of their products for testing by the agency.

Swiss drugmaker Novartis halted global distribution of its ranitidine drugs last month.

Last week, Walmart Inc joined pharmacy chains CVS Health Corp, Walgreens Boots Alliance Inc and Rite Aid Corp in suspending the sale of over-the-counter heartburn drugs containing ranitidine.

Canada's health authorities have asked makers of the drugs to halt distribution as they gather more information. Last month, regulators in Hong Kong pulled four products, while in Ireland 13 products containing ranitidine were recalled.

The impurity was believed to have been introduced by changes in the manufacturing process.

source: news.abs-cbn.com

Apple recalls MacBook Pros over battery fire risk

SAN FRANCISCO -- Apple has recalled a number of its older generation MacBook Pro because their batteries may overheat and "pose a fire safety risk." 

The recall affects 15-inch MacBook Pros with Retina displays sold between September 2015 and February 2017, the company said, adding it would replace batteries free of charge.

A number of countries are covered by the recall.

In mainland China, around 63,000 units may be affected by the problem, China's State Administration for Market Regulation said.

The regulator said there have been 6 reported incidents of overheating among laptops that qualify for the recall in China.

The tech giant, however, said it had not received any reports of significant damage to computers or injuries due to the defect, but urged owners of the affected devices to stop using them immediately.

It said a dedicated recall website has been set up where users can input the serial number to determine if their computer is affected.

The company said the recall does not include newer 15-inch MacBook Pro units or Apple laptops of other sizes and variations.

The battery recall marks the second technical glitch to affect Apple laptops this year. Last month, the US behemoth confirmed that some of its newer laptops had problematic keyboards and offered free replacements to affected customers.

In 2016, South Korean phonemaker Samsung suspended sales of its Galaxy Note 7 handset after devices caught fire due to flawed batteries exploding.

source: news.abs-cbn.com

Tesla recalls more than 14,000 cars in China over airbags

SHANGHAI, China - Tesla will recall 14,123 cars in China over airbags that contained parts made by now-defunct Japanese manufacturer Takata, the Chinese market regulator announced on Friday.

Tesla, which recently broke ground on a factory outside Shanghai, has said the move is part of an industry-wide global recall of parts made by Takata, which went bust in 2017 after its airbags were blamed for a number of deaths.

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Toyota recalls 1.7 million more autos in North America over airbag defects

NEW YORK -- Toyota on Wednesday announced a recall of 1.7 million vehicles in North America as part of a general effort to replace defective Takata airbags tied to some 20 deaths worldwide.

The Japanese auto manufacturer did not say whether it had been notified of injuries or serious incidents related to the latest recall.

The sprawling recall concerned 4Runner SUVs from model years 2010 to 2016, Corolla sedans and Matrix hatchbacks from 2010 to 2013 and Sienna minivans from 2011 to 2014.

The recall also involves Luxury Lexus models: ES 350 sedans (2010-2012), GX 460 SUVs (2010-2017), IS 250C and IS 350C convertibles (2010-2015), IS 250 and IS 350 sedans (2010-2013) and Lexus IS-F sedans (2010-2014).

Scion XB compacts from the 2010 to 2015 model years are also involved.

Dealerships will replace either the airbag inflators or entire airbag systems.

Last week, US automaker Ford recalled 953,000 vehicles to address Takata airbag problems.

This is Toyota's third large-scale Takata-related recall in 5 months. In November, the firm recalled 1.6 million vehicles worldwide.

US authorities in 2014 exposed the Takata airbag defect, which has since resulted in a series of massive recalls concerning at least 100 million units worldwide from multiple manufacturers.

About 20 people have died in accidents linked to the defect while the number of wounded is near 300.

The US National Highway Traffic Safety Administration says the Takata matter concerns 34 million vehicles and 46 million airbags in the United States but this could rise to 70 million by the end of 2019.

Founded in 1933, Takata went of business in June 2017 because of the crisis. The company was finally acquired last April for $1.6 billion by the equipment maker Key Safety Systems, with the resulting entity renamed Joyson Safety Systems.

source: news.abs-cbn.com

BMW recalls over 1 million cars over exhaust system fire risk

FRANKFURT AM MAIN - German high-end carmaker BMW said Tuesday it would recall more than one million additional diesel cars, citing a problem with the exhaust system that "in extreme cases can cause a fire".

"In some diesel vehicles, glycol cooling fluid can leak" from a faulty component called the exhaust gas recirculation cooler, which can combine with other substances in the system to create the fire risk, the group said.

BMW said it was contacting sellers who would in turn get in touch with owners of the affected vehicles to arrange a checkup.

"The exhaust recirculation module will be checked and if there is a fault the parts will be exchanged," the group said.

BMW had in August announced a recall for Europe and some Asian countries of over 480,000 vehicles affected by the same problem, and issued an apology in South Korea after around 30 cars caught fire there this year.

It said Tuesday it had checked more diesel models and identified a "minimal risk" of fire in some of them.

The latest recall brings the total number of cars affected to some 1.6 million around the world.

Shares in BMW shed 1.4 percent to trade at 73.38 euros ($84.21) in Frankfurt by 11:45 am (0945 GMT), against a DAX index of blue-chip German shares down 2.1 percent.

source: news.abs-cbn.com

Split concerns force Durex to recall condoms in UK, Ireland

LONDON - Durex, owned by Reckitt Benckiser, has recalled some batches of its “Real Feel” and “Latex Free” condoms in the United Kingdom and Ireland due to concerns they may burst.

“Our tests have shown that some batches which are currently on the market in UK & Ireland do not pass the requirements for burst pressure towards the end of the shelf life for the product,” Durex said in a statement.

Durex said only a limited number of batches were affected and that customers would be offered a full refund.

“Anyone using affected batches are advised to stop use over concerns they do not meet safety standards,” the Medicines and Healthcare products Regulatory Agency said in a statement.

“There is a risk that the condom might tear or leak reducing its protection from sexually-transmitted diseases and pregnancy.”

source: news.abs-cbn.com

Samsung recalls 2.8M washing machines in U.S. over injury risk

Samsung Electronics Co. Ltd., already reeling from a global recall of its Note 7 smartphones, said on Friday it would recall about 2.8 million top-load washing machines in the United States following reports of injuries.

The top of the washing machines can unexpectedly detach from the chassis during use, posing a risk of injury from impact, the U.S. Consumer Product Safety Commission said.

The South Korean tech company has received nine reports of injuries, including a broken jaw, an injured shoulder and other fall-related injuries, the agency said.

Samsung has received 733 reports of excessive vibration in the washing machines or the top detaching from the chassis.

The recall involves 34 models of top-load washing machines made between March 2011 and November 2016 and costing $450-$1,500.

The top of the affected washing machines could separate when a high-speed spin cycle is used for washing bedding, water-resistant or bulky items, Samsung said.

The company has also been sued by some U.S. customers, who have alleged that their machines "explode during normal use".

Samsung, the world's top smartphone maker, scrapped its Galaxy Note 7 smartphone last month after failing to resolve safety concerns.

It had announced the recall of 2.5 million Note 7s in early September following numerous reports of the phones catching fire.

source: www.abs-cbnnews.com

California fruit recalled due to possible Listeria

OTTAWA – Some fruit products imported from California are being recalled due to concerns about possible Listeria monocytogenes contamination.

The Canadian Food Inspection Agency says the whole peaches, plums, nectarinees and pluots are sold primarily the Sweet 2 Eat brand.

The products, being recalled by Wawona Packing Company of California, may also show the Wawona or Harvest Sweet brand names.

Stickers on individual fruit have the Sweet 2 Eat brand name, and there are 45 packaging variations for the fruits involved.

The CFIA says the fruits may have been sold nationally and says there have been no reported illnesses linked to eating these products.

The federal agency says the recalled products should be thrown out or returned to the store where they were purchased.

source: globalnews.ca

FDA orders recall of 6 S.Korean noodle brands

MANILA - Philippine authorities have ordered the recall of six brands of South Korean noodles from local shops after they were reported to contain a cancer-causing chemical.

The Food and Drug Administration said in a statement dated Thursday that the noodles made by Nongshim Co, "will be off the shelves immediately", and called on the public to report if they were still being sold.

"The government is also undertaking inspection, collection and testing of other brands of noodles not currently identified to be contaminated as a precaution," the statement on the agency's website said.

The Philippine agency said its South Korean counterpart had found that the six brands contained "benzopyrene, a chemical with carcinogenic potential" in its tests.

The statement did not say if the Philippine agency had tested the Nongshim brands itself. Spokesmen of the local FDA could not be contacted for comment.

China, Taiwan and Vietnam have all reportedly had similar recalls of the same brands of South Korean noodles over similar health fears.

source: abs-cbnnews.com