The Jim Bakker Show

Toyota recalls 1.7 million vehicles worldwide over air bag inflators

By David Shepardson

WASHINGTON (Reuters) – Toyota Motor Corp said Wednesday it is recalling another 1.7 million vehicles worldwide for potentially faulty Takata airbag inflators as part of a multi-year industry recall campaign announced in 2016.

Automakers are adding about 10 million vehicle inflators in the United States to what was already the largest-ever recall campaign in history. Last week, Ford Motor Co said it was recalling 953,000 vehicles worldwide for Takata inflators. Previously, 37 million U.S. vehicles with 50 million inflators were recalled and 16.7 million inflators remain to be replaced.

At least 23 deaths worldwide have been linked to the rupturing of faulty Takata air bag inflators, including 15 in the United States.

Toyota’s new recall relates to vehicles from the 2010 through 2015 model years, and includes 1.3 million vehicles in the United States.

More than 290 injuries worldwide have been linked to Takata inflators that could explode, spraying metal shrapnel inside cars and trucks. In total, 19 automakers are recalling more than 100 million potentially faulty inflators worldwide.

To date, 21 deaths have been reported in Honda Motor Co vehicles and two in Ford vehicles. Both automakers have urged some drivers of older vehicles not to drive them until the inflators are replaced.

The defect led Takata to file for bankruptcy protection in June 2017. In April, auto components maker Key Safety Systems completed a $1.6 billion deal to acquire Takata. The merged company, known as Joyson Safety Systems, is a subsidiary of Ningbo Joyson Electronic Corp.

Automakers in the United States repaired more than 7.2 million defective Takata airbag inflators in 2018 as companies ramped up efforts to track down parts in need of replacement, according to a report released last month.

(Reporting by David Shepardson, Editing by Franklin Paul and Bernadette Baum)

Toxin at heart of drug recall shows holes in medical safety net

FILE PHOTO: The headquarters of the European Medicines Agency (EMA), is seen in London, Britain, April 25, 2017. REUTERS/Hannah McKay -/File Photo

By Alexandra Harney and Ben Hirschler

SHANGHAI/LONDON (Reuters) – A toxin inadvertently produced in the manufacture of a widely prescribed medicine but not spotted for years raises questions about regulators’ ability to detect risks in a sprawling global drug supply chain increasingly reliant on factories in China.

China’s Zhejiang Huahai Pharmaceutical, which produces bulk ingredients for drugmakers, told its customers in late June it had found NDMA in its valsartan, an off-patent blood pressure drug originally developed by Novartis.

The discovery means that some of the 10 billion pills containing valsartan sold worldwide last year to prevent heart attacks and strokes had traces of N-nitrosodimethylamine (NDMA), classified as a probable human carcinogen. No one has been reported as sickened by the toxin, once used in the production of liquid rocket fuel.

Regulators and industry experts say the toxin almost certainly was introduced when Huahai changed the way it produced valsartan in 2012 – a modification that was signed off on by the European body that sets standards. Subsequent inspections by European, U.S., and Chinese regulators also found no problem.

“Everyone failed – the company, the inspectors, the FDA (U.S. Food and Drug Administration), the Europeans, the Chinese,” said Philippe André, an independent pharmaceutical auditor who inspected two Huahai facilities last August and found no critical concerns. “It’s a system failure.”

Reuters was unable to determine how Huahai first discovered the problem. In a July 7 statement released through the Shanghai Stock Exchange, it said it detected the toxin during the “optimization and evaluation” of its manufacturing process.

A Novartis spokesman told Reuters that its generic drugs arm, Sandoz, spotted the NDMA in the course of intensive testing to prepare for expanding its purchases of valsartan. He declined to comment further, including on the identity of the manufacturer or when the tests took place.

Two other smaller bulk suppliers – Zhejiang Tianyu Pharmaceutical and a unit of India’s Hetero Drugs – have since also discovered traces of NDMA in some of their valsartan.

The three companies declined to comment to comment about the case.

REDUCE WASTE

Huahai said in a document released through the Shanghai Stock Exchange it changed the production process to reduce waste and improve yields.

“The NDMA impurity was produced in trace amounts during the normal manufacturing process according to the company’s current registered process,” it said in a statement on July 24.

“All changes in the company’s valsartan manufacturing process have been approved by each country’s drug regulator, and the company manufactures in compliance with legal and regulatory standards.”

The European Medicines Agency (EMA) regulator, which first publicly raised the alarm in a statement on July 5, told valsartan suppliers in a subsequent memo dated July 16 that the NDMA may have been connected to the combined use of the solvent dimethylformamide and sodium nitrite.

The FDA is also going on that hypothesis, said Janet Woodcock, director of its Center for Drug Evaluation and Research. She stressed the investigation was still going on.

“This (NDMA) was not what you look for in an inspection,” Woodcock said in an interview. “If you don’t test for this you’re not going to have an idea that it’s in there, and you’re not going to see it on an inspection.”

The European Directorate for the Quality of Medicines (EDQM), responsible for setting manufacturing standards, told Reuters it was aware the solvent was being used when it approved the changed process, but that NDMA as a by-product was unexpected and not tested for.

Detecting NDMA would have required gas chromatography coupled with mass spectrometry, a very sensitive level of testing, an EDQM spokeswoman said.

“These techniques are not normally used routinely to test pharmaceutical products,” she said.

RECALLS

Built by Novartis into the $6 billion-a-year brand Diovan, valsartan’s European and U.S. patents expired in 2011 and 2012.

Global sales totaled 10.4 billion pills last year, including combination products, healthcare data consultancy IQVIA estimates. People with high blood pressure typically take one pill daily and heart failure patients two.

More than 50 companies around the world making finished tablets from the tainted valsartan have recalled products in recent weeks, according to a Reuters analysis of national medicines agencies’ records. They include major generic drug manufacturers such as Teva Pharmaceutical Industries, Ranbaxy Laboratories, and Sandoz.

Based on the average NDMA impurity detected at Huahai of 60 parts per million (ppm), the EMA says there could be one additional case of cancer in every 5,000 people taking the highest dose for seven years.

The contamination puts a spotlight on manufacturers in China and India, which supply more than two-thirds of all active pharmaceutical ingredients used in medicines, industry executives estimate. China accounts for the lion’s share.

Huahai, founded in 1989 and listed in Shanghai in 2003, was one of the first Chinese companies to get drugs approved in the U.S. market.

The FDA has inspected the site that made the contaminated valsartan three times since 2010, its records show. European inspectors also visited regularly.

The provincial branch of the Chinese FDA (CFDA) also inspected Huahai facilities 10 times in connection with new drug applications between January 2016 and June 2018, the national online database shows.

SCRUTINY

U.S. and European regulators have increased scrutiny of Chinese and Indian drug factories after the adulteration of the blood thinner heparin sickened hundreds and caused the deaths of at least 81 Americans in 2007 and 2008.

The CFDA is also on alert.

Last month, it revealed that Changsheng Bio-technology , a vaccine maker, had fabricated data and sold ineffective vaccines for children. It also found that a diphtheria, tetanus and pertussis vaccine sold by the state-owned Wuhan Institute of Biological Products was substandard.

The fact that international inspections do not appear to have detected the NDMA contamination alarms Anders Fuglsang, a former European medicines regulator who runs a pharmaceutical consultancy in Denmark.

“We need to ask ourselves how it is possible – despite pharmacopoeias and agency guidelines, inspection programs with coordination across continents, a system of public quality control, and companies complying with all rules – that a nasty carcinogen can find its way into our drugs and be there for years without anyone noticing,” he said.

(Additional reporting by Shanghai newsroom, Zeba Siddiqui in Mumbai and Sharnya G in Bengaluru; Editing by Sonya Hepinstall)

Toyota expands U.S. Takata air bag recall to 600,000 extra vehicles

By David Shepardson

WASHINGTON (Reuters) – Toyota Motor Corp said on Tuesday it was expanding its safety recall involving Takata Corp front passenger air bag inflators to cover about 601,300 additional vehicles in the United States.

Takata and its U.S. entity TK Holdings Inc filed for bankruptcy in June after it said it was recalling more than 100 million of its air bag inflators worldwide through the end of 2019 because they could inflate with too much force and spray metal fragments.

Air bags with the inflators have been linked to at least 180 injuries and 20 deaths, mostly in the United States including one in Louisiana that was identified last month.

The U.S. National Highway Traffic Safety Administration on Saturday posted a notice from Takata that said the company would recall another 3.3 million inflators for vehicles from automakers including Toyota, Honda Motor Co, BMW AG, Daimler AG, General Motors Co, Tata Motors Jaguar Land Rover unit and Subaru Corp.

NHTSA said in November that 19 automakers had recalled 46 million inflators in 34 million U.S. vehicles — and by 2019 as many as 70 million U.S. inflators will have been recalled. In June, the agency said only about 35 percent of vehicles recalled have been repaired to date.

In January 2016, Takata agreed to plead guilty to criminal wrongdoing and pay $1 billion to resolve a U.S. Justice Department investigation into the inflator ruptures.

(Reporting by David Shepardson in Washington and Sanjana Shivdas in Bengaluru; Editing by Tom Brown)

Ford to recall about 1.3 million vehicles in North America

(Reuters) – Ford Motor Co said on Wednesday it would recall about 1.3 million vehicles in North America, including certain 2015-17 Ford F-150 and 2017 Ford Super Duty trucks, to add water shields to side door latches. (http://ford.to/2ySvCBJ)

The No.2 U.S. automaker said the safety recall is due to frozen door latch or a bent or kinked actuation cable in the affected vehicles, that may result in a door not opening or closing.

The company said it was not aware of any accidents or injuries associated with the issue but said because of the fault the door may appear closed, increasing the risk of the door opening while driving.

The cost of the recall was estimated to be $267 million and would be reflected in its fourth quarter results, the company said. (http://bit.ly/2yT3EWu)

Ford said it continues to expect full-year adjusted earnings in the range of $1.65 to $1.85‍ per share.

(Reporting by Ankit Ajmera in Bengaluru; Editing by Anil D’Silva and Arun Koyyur)

IKEA recalls 36 million chests and dressers after six deaths

WASHINGTON (Reuters) – Swedish furniture company IKEA Group [IKEA.UL] is recalling almost 36 million chests and dressers in the United States and Canada but said the products linked to the deaths of six children are safe when anchored to walls as instructed.

The recall covers six models of MALM chests or dressers manufactured from 2002 to 2016 and about 100 other families of chests or dressers that the U.S. Consumer Product Safety Commission said could topple over if not anchored securely to walls, posing a threat to children.

“It is simply too dangerous to have the recalled furniture in your home unanchored, especially if you have young children,” CPSC Chairman Elliott Kaye said in a statement on Tuesday.

Tipped-over furniture or television sets kill a U.S. child every two weeks, he added.

IKEA said that the recall was based on a standard applicable in North America for free-standing clothing storage units and that the products meet all mandatory stability requirements in Europe and other parts of the world.

“When attached to a wall the products are safe. We have had no other issues with that in any other country,” said Kajsa Johansson, a spokeswoman for IKEA in Sweden.

IKEA said it had no details on potential costs stemming from the recall.

A recall summary from the company said that the chests and dressers are unstable if not properly anchored to a wall, posing a serious tip-over and entrapment hazard that could result in death or injury to children.

Two U.S. toddlers died in separate 2014 incidents when MALM chests fell on them. A 22-month-old boy was killed last year in a similar incident, which occurred after IKEA had announced a repair program including a free wall-anchoring kit.

None of the furnishings in the fatal incidents had been anchored to a wall.

IKEA had received reports of 41 tip-over incidents involving non-MALM chests that caused 19 injuries and the deaths of three children from 1989 to 2007.

As part of the recall, IKEA is offering refunds or a free wall-anchoring kit.

The U.S. recall covers about 8 million MALM chests and dressers and 21 million other models of chests and dressers. About 6.6 million are being recalled in Canada.

Ikea has sold approximately 147.4 million chests of drawers globally since 1998.

(Reporting by Ian Simpson in Washington DC and Mia Shanley in Stockholm; Editing by Dan Grebler and David Goodman)

FDA too slow to order food recalls, U.S. watchdog finds

By Julie Steenhuysen

CHICAGO (Reuters) – The Food and Drug Administration is too slow to order companies to recall tainted foods, leaving people at risk of illness and death, a government watchdog said in a review of the agency’s food safety program.

The Department of Health and Human Services’ Office of Inspector General reviewed 30 recalls that occurred between 2012 and 2015, including two in which companies did not recall all affected items until 165 days and 81 days after the FDA became aware of tainted foods. The watchdog issued its report on Wednesday.

“FDA does not have adequate policies and procedures to ensure that firms take prompt and effective action in initiating voluntary food recalls,” the report said. “As a result, consumers remained at risk of illness or death for several weeks after FDA was aware of a potentially hazardous food in the supply chain.”

The watchdog urged the FDA to address the problem immediately.

In a blog post, FDA food safety officials Stephen Ostroff and Howard Sklamberg called the report’s findings “unacceptable” and said the agency is “totally committed” to food safety.

Representative Rosa DeLauro of Connecticut in a statement said it was “mind-boggling” that the FDA does not have policies or procedures to ensure swift voluntary food recalls.

DeLauro, who oversees drug and food safety in her position on the House of Representatives subcommittee responsible for the FDA, pointed to a salmonella outbreak last year in cucumbers, which sickened nearly 900 people, hospitalized 191 and killed six. The outbreak began in July, but it took until September before producers started recalling product.

“Delays like this one – and others found in the report – are completely unacceptable and leave American consumers at risk for illness and death,” DeLauro said.

Ostroff and Sklamberg said the FDA has a plan underway to strengthen compliance and enforcement policies, including both voluntary and mandatory recalls.

But they said recalls must be based on scientific evidence borne out of an outbreak investigation. And while timeframes for recalls need to be set, “they must be done on an individual basis rather than by setting arbitrary deadlines.”

To speed the FDA’s response, Ostroff and Sklamberg said the agency has established a team of experts from different scientific disciplines to oversee outbreak investigations. They also cited FDA’s adoption in 2014 of the use of whole genome sequencing, a more precise technology for determining the genetic fingerprint of foodborne pathogens.

In addition, provisions in the 2011 Food Safety Modernization Act that require companies to minimize food safety risks, and require companies to have a recall plan, will begin to take effect this fall.

(Reporting by Julie Steenhuysen; Editing by Leslie Adler)

G.M. recalls 1.04 million newer trucks

WASHINGTON (Reuters) – General Motors Co said Friday it is recalling nearly 1.04 million newer pickup trucks for a seat belt flaw.

The largest U.S. automaker said the recall of the 2014-15 Chevrolet Silverado and GMC Sierra 1500 pickups is not linked to any crashes or injuries. GM said the cost of the large recall “is not expected to be significant and is covered within normal and customary warranty reserves.”

GM said the recall in the United States includes 895,232 vehicles and a stop-sale of approximately 3,000 new 2014 and 2015 model year pickups still on dealer lots.

GM said the recall was prompted by warranty data that showed the flexible steel cable that connects the seat belt to the vehicle can separate over time as a result of the driver repeatedly bending the cable when entering the seat.

Dealers will enlarge the side shield opening, install a bracket on the tensioner, and if necessary, replace the tensioner assembly.

The recall includes about 142,000 vehicles outside the United States.

(Reporting by David Shepardson; Editing by Chizu Nomiyama and Nick Zieminski)

Hyundai recalls 173,000 Sonata Cars

(Reuters) – Hyundai Motor Co will recall 173,000 model year 2011 Sonata cars in the U.S. market for a potentially defective power steering system, U.S. safety officials said in a filing on Friday.

The National Highway Traffic Safety Administration (NHTSA) said the cars made from late December 2009 through late October 2010 may have a damaged circuit board that could cause the loss of power steering.

The loss of power steering can increase the risk of a crash, particularly at low speeds, NHTSA said.

The company told the NHTSA it has not identified any crashes or injuries related to the issue.

Hyundai told the NHTSA that it has been making the Sonata sedan for the U.S. market since December 2009, and by March 2015, the number of warranty claims due to lost power steering triggered a company investigation.

In January of this year, it was determined that before October 2010, when a supplier upgraded the protective covering of the circuit board, the boards could be damaged over time.

(Reporting by Bernie Woodall in Detroit; Editing by Jeffrey Benkoe)

New Takata air bag recall to cover 5 million U.S. vehicles

(Reuters) – U.S. regulators on Friday announced a new recall of about 5 million vehicles with potentially defective Takata Corp air bags, covering some automakers not previously affected by one of the biggest auto safety recalls in U.S. history.

The new action brings to 28 million the number of Takata air bag inflators recalled and increases the number of vehicles affected in the United States to as many as 24 million, the National Highway Traffic Safety Administration (NHTSA) said.

Friday’s move was prompted in part by the death of the driver of a Ford Motor Co pickup truck last month, as well as new tests conducted on suspected faulty air bags.

Automakers affected for the first time include Volkswagen AG and its Audi unit and Daimler’s Mercedes-Benz unit.

“This is a massive safety crisis,” NHTSA spokesman Gordon Trowbridge told reporters.

NHTSA in November said tens of millions of additional vehicles with inflators containing ammonium nitrate will be recalled by 2018 unless Takata can prove that they are safe.

The Dec. 22 death of a Georgia man in South Carolina was the 10th worldwide linked with Takata’s air bag inflators, NHTSA said. It was also the first to occur in a vehicle that was not made by Honda Motor Co.

The 5 million vehicles covered by the new recall include about 1 million with inflators similar to those installed on the Ford Ranger pickup, NHTSA said.

About 4 million other vehicles will be recalled due to additional testing on Takata air bags, including vehicles from Honda, VW and other automakers, the safety agency said.

Twelve major automakers have previously recalled more than 23 million Takata air bag inflators in more than 19 million vehicles in one of the largest and most complex safety recalls in U.S. automotive history.

NHTSA did not immediately say how many of the 5 million vehicles being recalled Friday may have been covered by previous recalls.

Takata’s inflators can explode with too much force and spray metal shrapnel into vehicle passenger compartments and are linked to more than 100 U.S. injuries.

A South Carolina attorney said in a complaint filed with NHTSA that his client was killed when “metal from the inflator canister exploded penetrating my client’s neck resulting in death.”

The attorney, Andrew Creech, said in the complaint, “There is no doubt airbag shrap (shrapnel) metal killed my client, as this has been confirmed by death certificate and autopsy report.”

The man killed in the 2006 Ford Ranger struck a cow that was in the road, Creech’s report to NHTSA said.

Creech was not available for comment on Friday.

In November, Takata agreed to pay a $70 million fine for safety violations and could face deferred penalties of up to $130 million under a NHTSA settlement.

NHTSA in December named a former Justice Department official as a monitor to help regulators oversee the massive recalls.

The Ford death is the first reported since the July crash of a 2001 Honda Accord coupe that killed a 13-year-old near Pittsburgh, Pennsylvania.

(Reporting by David Shepardson; Editing by Tom Brown)

Trader Joe’s recalls cashews amid salmonella concerns

A possible salmonella contamination has prompted Trader Joe’s to recall some cashews.

The grocery store chain issued a statement about the recall late last week, saying that one particular kind of Trader Joe’s Raw Cashew Pieces could be contaminated with the bacteria.

The cashews are marked “BEST BEFORE 07.17.2016TF4,” the company said, and were distributed to stores in 30 states across the country, as well as the District of Columbia.

It wasn’t clear exactly how many packages were included in the recall.

Trader Joe’s said it learned of the possible contamination from a supplier, but didn’t elaborate.

A recall notice on the Food and Drug Administration website says Heritage International (USA) Inc. was voluntarily recalling the cashew lot after routine lab tests found salmonella in it.

The bacteria can cause people to fall ill.

Trader Joe’s said it hasn’t received any reports of anyone getting sick from the cashews, though it has stopped selling all Trader Joe’s Raw Cashew Pieces in its stores pending an investigation.

The grocery chain encourages anyone who bought the cashews marked “BEST BEFORE 07.17.2016TF4” to return them for a full refund or throw them out without eating them.

According to the CDC, salmonella sickens about 1.2 million Americans every year. Symptoms include diarrhea, fever and abdominal cramps, and most people fully recover in 4 to 7 days. In extreme cases, though, infections can spread beyond the intestines and become more severe.

The bacteria leads to about 450 deaths and 19,000 hospitalizations every year, the CDC says. Children, older adults and people with weak immune systems are particularly at risk.

Sign up for Jim Bakker Show