Reumofan Plus USA, LLC and Reumofan USA, LLC is Voluntarily Recalling all lots of Reumofan Plus Tablets Due to Undeclared Drug Ingredients

 

 

Feb. 15, 2013 - SPRINGFIELD, Pa., /PRNewswire/-- Reumofan Plus USA, LLC and Reumofan USA, LLC is recalling "Reumofan Plus" Tablets, Lot# 99515, exp. 09/16, because they contain undeclared active pharmaceutical ingredients: methocarbamol, dexamethasone, and diclofenac. Use of this product could result in serious and life-threatening injuries

Hip implant recipient feared revision surgery.

In continuing coverage, Bloomberg News (2/20, Possley, Voreacos) reports, "A Montana man suing Johnson & Johnson's DePuy unit over his metal-on-metal hip implant told a Los Angeles jury" on Tuesday that he "feared" the revision surgery "he had last February to remove his ASR hip implanted in December 2007" would kill him. The plaintiff Loren Kransky, who is suing DePuy on allegations that debris from his hip implant blackened tissue and poisoned his bloodstream, told the state court jury, "I had 25 surgical procedures done prior to that. ... I thought that surgery was going to kill me." Kransky's case is the first of the 10,000 pending lawsuits to go to trial over the ASR XL hip implants, 93,000 of which were recalled in August 2010 over exceptionally high failure rates

Johnson & Johnson recalls Adept Hip Implants

Medical-device firm's unit recalls more hip implants over high failure rates.

The AP (2/15, Johnson, Jordans) reports that spokespersons for Johnson & Johnson's DePuy Orthopaedics unit on Thursday said that on Jan. 14, the company "notified surgeons and hospitals" that it was recalling its all-metal, Adept hip implants because a data review of national registries in the UK and Australia revealed a "higher-than-expected percentage of them had to be replaced." The UK registry data showed "12.1 percent of patients needed their implants replaced within seven years," whereas the Australia registry data revealed "7.1 percent of patients needed replacements within three years." The recall "involves only the top part of the hip replacement system, the ball at the top of the thigh bone that fits into the hip's socket."

        According to Bloomberg News (2/15, Pettypiece, Cortez), J&J said "about 7,500" of the hip implants, which have not been on the market since 2011, "were distributed in 21 countries not including the US." Notably, the New Brunswick, New Jersey-based healthcare products company "recalled 93,000 of its ASR model hips in August 2010 and faces 10,000 lawsuits," the first of which is presently underway in a Los Angeles state court.

Air Bag Defects Inflate Auto Safety Recalls

Air bags may save lives in car crashes, but increasingly, they're becoming safety problems themselves -- at least when it comes to an increasing frequency of recalls.

Already this year, Honda and Toyota have launched air bag-related recalls covering 1.5 million vehicles. That follows a record year for recalls involving air bags -- 22 spread across 18 brands in 2012.

The problems don't appear to be that air bags are any worse than they've ever been. Rather, there are more of them being packed into cars. They're in new places and are more sophisticated. Together, those factors add up to more recalls, and more vehicles affected -- since 2011, air bag recalls have involved nearly 7.75 million vehicles, more than the previous eight years combined.

"It's a complex system, and that complexity implies more components," says Honda spokesman Chris Martin.

There's no debate about air bags' effectiveness. A National Highway Traffic Safety Administration study found that air bags saved 2,788 lives in one sample year. At issue is whether they'll inflate when they're supposed to, or whether they'll cause injuries on their own.

That was the fear with Honda's recall last month. It recalled 748,481 vehicles -- 2009 to 2013 model year Pilot SUVs and 2011 to 2013 Odyssey minivans -- for missing rivets on an air bag cover. The driver could be hurt if the air bag deploys when all six rivets aren't in place.

Toyota's recall of 887,709 vehicles -- 2003 and 2004 Toyota Corollas, Matrixes and Pontiac Vibes -- centered on a circuit board that can short out due to interference from other electric components. If that happens, the automaker warns in its filing to regulators, an air bag could accidentally deploy.

While both problems were caught by engineers before they could injure passengers, that's not always the case. In recalling 744,822 Jeeps last November, Chrysler Group noted 126 inadvertent air bag deployments caused 59 minor injuries in 2002 to 2003 Libertys and 89 deployments caused 22 minor injuries in 2002 to 2004 Grand Cherokees. The problem involved faulty circuit boards.

Air bags inflating without a crash is one problem, when detectors that are supposed to sense a crash trigger the air bags, says Sean Kane of Safety Research & Strategies. Sometimes, bags inflate prematurely, then deflate before a person is cushioned.

At the same time, automakers are making complex air bag systems. They're:

• Adding more. Automakers continue to pack them in. The 2013 Dodge Dart has 10. Toyota's newest RAV4 crossover has eight.

• Finding new places. General Motors has the first front-center air bags in the 2013 Buick Enclave, Chevrolet Traverse and GMC Acadia to keep the driver and front-seat passenger from colliding in a crash. Toyota has the first rear air bag to protect back-seat passengers in a rear-end crash in the tiny Scion iQ.

• Incorporating new technology. Ford's Lincoln unit is putting inflating seat belts in the rear of its 2013 MKZ sedan and MKT SUV. They put an air bag in a shoulder belt to better distribute forces.

While the advances are sure to save lives and lessen injuries, there's more that can go wrong.

"You are relying on millions of lines of codes to make decisions within milliseconds," Kane says. With all the snafus, some airbags hold the potential to "create more injuries than they can prevent."

Mitsubishi recalls 1,400 I-Miev electric vehicles.

The Los Angeles Times (2/5, White, 692K) reports, "Mitsubishi Motors North America is recalling certain model year 2012 i-MiEV electric vehicles that were manufactured from Dec. 2, 2011, through Sept. 7, 2012, according to the National Highway Traffic Safety Administration." The Times notes that "the brake system vacuum pump on those vehicles may fail, rendering the vacuum pump inoperable" and "if the vacuum pump system fails, the recall notice says, it will reduce available brake power, which would result in lengthened stopping distances and could increase the risk of a vehicle crash."*

        Cars (2/5, Geiger) also notes that "Mitsubishi is recalling 1,402 model-year 2012 versions of the i-MiEV compact electric car due to problems with the brakes, according to the National Highway Traffic Safety Administration."

        Also reporting on the recall are the Detroit Free Press (2/6, 280K), the AP (2/6, Press), and the Wall Street Journal (2/6, Welsh, 2.29M).

Toyota Recalls for Airbag Sensor Problems

Toyota is recalling certain models interspersed through model years 2009 through 2013 as follows: model year 2009-2012 Tacoma, 4Runner, Camry, Camry Hybrid, Prius, and RAV4; model year 2009-2010 Avalon, FJ Cruiser, and Highlander Hybrid; model year 2010-2013 model year Corolla, Sienna and Tundra; model year 2009-2013 Highlander and Venza; model year 2012 Prius V; and model year 2010-2012 Sequoia. During modification by SET to include accessories such as leather seat covers, seat heaters or headrest DVD systems, these vehicles may not have had the passenger seat occupant sensing system calibration tested. Without passing the calibration test, the occupant sensing system may not operate as designed.

Consequence:   If the front passenger seat occupant sensing system is out of calibration, the front passenger airbags may not deploy or they may deploy inappropriately for the passenger's size and position. This could increase the risk of personal injury during the event of a vehicle crash necessitating airbag deployment.

Remedy:   Southeast Toyota will notify owners, and dealers will test the sensitivity of the occupant detection sensors, and recalibrate them as necessary. The recall is expected to begin during January 2013. Owners may contact Southeast Toyota at 1-800-301-6859.

Notes:   Owners may also contact the National Highway Traffic Safety Administration Vehicle Safety Hotline at 1-888-327-4236 (TTY 1-800-424-9153), or go to www.safercar.gov.

Expert: metal debris led to hip implant failure.

In continuing coverage on claims alleging Johnson & Johnson's DePuy unit failed to warn consumers that its ASR hip implants were defective, Bloomberg News (2/2, Possley, Voreacos, Feeley) reported that toxicologist Robert Harrison told jurors Friday in a Los Angeles state court that DePuy "failed to consider the harmful effects of chromium and cobalt debris in designing the 93,000 all-metal hip implants" that were later recalled. He noted that according to the California Poison Control System, "cobalt levels above 7 micrograms per liter are harmful." Within three years of receiving his hip implant, the plaintiff, Loren Kransky, had a cobalt level in his blood stream that was "almost eight times the acceptable level." In contrast, the FDA in a Jan. 17 advisory said it "does not have enough scientific data to specify the concentration of metal ions in a patient's body or blood necessary to produce adverse systemic effects."

        Reuters (2/2, Beasley) added that Kransky's Lawyers contend that DuPuy already knew the ASR hip implant had several defects, including the risk for metal poisoning from cobalt and chromium debris, before it launched the metal-on-metal devices on the US market in 2004. In addition, Reuters quoted Harrison, who was asked for his opinion during the hearing, as saying that after reviewing Kransky's medical file, he "concluded that his hip failed because of the toxic exposure."

GM issues two recalls for over 12,000 vehicles.

The Los Angeles Times (1/31, Undercoffler, 692K) reports that General Motors has announced a pair of recalls. "The first recall is for 8,519 Chevy Malibu sedans from the 2013 model year." The NHTSA says one or more bolts in the vehicles' rear suspension may not have been fastened tight enough which could cause "sudden changes in the vehicle handling" which may lead to a crash. No injuries or crashes have been reported. "The second recall affects 3,896 Chevy Camaro, Buick Verano, Chevy Cruze and Chevy Sonic vehicles from the 2012 model year" which "have a problem with the drivers' airbag that can prevent it from deploying in the event of a crash." No injuries or crashes have been reported.

        Also reporting on the recall are the Detroit News (1/31, Shepardson, 119K), Cars (1/31, Geiger), MSN Autos (2/1), and Reuters (1/31).

Jury told medical-device firm unit had "inappropriate" risk controls regarding hip implants.

In continuing coverage on claims alleging Johnson & Johnson's DePuy unit failed to warn consumers that its ASR hip implants were defective, Bloomberg News (2/1, Possley, Voreacos, Feeley) reports DePuy's Compliance Manager Jimmy Smith on Thursday told a California jury that the company "took 'inappropriate' steps to identify and eliminate risks in the design of 93,000 all-metal hip implants" that J&J recalled in August 2010. Smith, who "oversaw a 2011 review of a design team's safety standards for the ASR hip cup," said his audit "found that a DePuy group used irrelevant controls in a so-called failure mode and effect analysis, or FMEA, before the ASR was sold in 2005 in the US." In fact, the audit discovered numerous FMEAs were assessed using controls that were either inappropriate or extraneous, Smith admitted during his testimony at the state court in Los Angeles.

        The New York Times (2/1, B2, Meier, Subscription Publication, 1.68M) adds that also on Thursday, DePuy engineer Graham Isaac told the jury that before putting the ASR on the market, the company conducted a performance tests on "laboratory equipment at one angle of implantation"; and because the product design was flawed, "normal variance" from the angle that was tested increased the likelihood for the "joint's cup and ball components to strike each other, releasing metallic debris inside a patient." Moreover, Smith testified that DePuy never released a summary of a "post-mortem review" of the ASR that it conducted in November 2010 and neglected to perform a similar analysis "in response to the mounting number of complaints about the device that it received from doctors and others in 2008 and 2009."