Articles Posted in Recalls

The Children’s Hospital of Philadelphia (CHOP) has been conducting a study on polyethylene glycol 3350 (PEG 3350), the active ingredient in MiraLAX, and its effect on a child’s brain. The study came about after reports that children have been experiencing behavioral problems after taking MiraLAX.

What is MiraLAX and how is it different?

MiraLAX is a laxative that. MiraLAX has branded itself as being different from other laxatives by having fewer side effects. The medication’s own website notes that it works with your body’s natural process to provide relief from constipation. It claims that working with the body prevents harsh side effects. This contrasts from stimulant laxative pills, which forcefully stimulates nerves in your colon.

This is just crazy.  It what appears to be a rerun of a rerun, the FDA has once again updated its recall list of valsartan-containing products. If you are currently taking Valsartan, you must check that list to see your medication may or may not be on it. If you are unaware of the previous valsartan recalls, please inform yourself as this will help you become more informed on how these medications may affect your overall health. You must also know about the lawsuits involving NDMA-contaminated valsartan, as it shows what kind of hardships people might experience after taking these tainted drugs.

  1. What was added to the recall list?

The FDA added valsartan-containing products under the brand name RemedyRepack to its recall list. Their tests determined that the valsartan brand contained N-nitrodimethylamine (NDMA), which is considered a carcinogen by both the Environmental Protection Agency (EPA) and the FDA. The pharmaceutical companies Prinston and Solco distribute this brand. Both Prinston and Solco are involved in class action lawsuits throughout the United States that involve their distribution of already recalled valsartan-containing products. This updated recall list highlights the extent of how many valsartan-containing products are contaminated.

If you have a Ethicon Physicomesh lawsuit, here are 8 things you want to know.

  1. Ethicon Physiomesh

The Physiomesh was introduced in 2010 and had an absorbable film coating on each side of the mesh. It was designed to minimize inflammation and incorporate the patch into the body. Ethicon, a subsidiary of Johnson & Johnson, manufactured the Physiomesh.

On September 11th, James Jones, a Missouri man, filed an MDL class action lawsuit in the U.S. District Court for the Eastern District of Missouri. This Valsartan lawsuit was filed against several manufacturers of the drug Valsartan, which is used to treat heart failure and high blood pressure.

What does this mean?  It means that the Valsartan cases are now moving forward very quickly.

In a few short months, we could have a full-blown MDL class action lawsuit with thousands of potential plaintiffs.

Yesterday, I wrote an article noting a Danish study that concluded that there were no long-term cancer risks associated with NDMA-contaminated valsartan tablets. While NDMA might not have long-term cancer risk effects, it is not the only impurity found in valsartan.

On September 13, Health Canada announced that another impurity, N-nitrosodiethylamine (NDEA), was found in valsartan that was manufactured by Zeijiang Huahai Pharmaceuticals (ZHP) in China.

The FDA has also discovered NDEA in some ZHP-manufactured valsartan through testing. According to the European Medicines Agency (EMA), NDEA has been found in valsartan made by ZHP since they changed its manufacturing process in 2012. NDEA, like NDMA, is classified as a possible human carcinogen.

On August 30, 2018, General Motors announced a recall on 210,628 vehicles in the United States and 19,385 vehicles in Canada because of an issue involving brake pedals. This recall affects different 2018 and 2019 models including the Chevrolet Bolt, Cruze, Equinox, Impala, Malibu, and Volt. It also affects the 2018 and 2019 models of the Buick Cadillac XTS, LaCrosse, Regal, and GMC Terrain as well.  Let’s just say this is a huge recall that appears to have had an impact of GM’s stock. It has been heading south since the recall. Why?  Recalls cost a lot of money that should be in the pocket of shareholders.

Why the recall?

The cars recalled had rear-brake pistons that were improperly chromed and tempered during the manufacturing process. This can cause hydrogen gas to be trapped inside the piston. If the piston containing hydrogen gas contacts brake fluid, this gas can be released into the vehicle’s overall brake system. This can affect rear-brake performance and increase crash risk.

On September 6, 2018, the National Highway Traffic Safety Administration (NHTSA) acknowledged a recall of the 2018 edition of Volkswagen’s Atlas SUV.

Why the recall?  Some Atlas’ airbags may deploy randomly, potentially injuring its occupants. According to Volkswagen, they received one report involving curtain airbags being deployed randomly. Volkswagen Group of America, Inc. is recalling about 9,600 vehicles. Each of them was manufactured at its Chattanooga, Tennessee plant.

The cause of this error is because of improper part installation. During production, the air condition evaporator drain tube contorted into an irregular position. This resulted in water drain into the airbag control module rather than outside of the car. A wet airbag control module can result in an unintended airbag deployment. Random airbag deployment can increase the risk of both injury and accident. The twisted tube may also leak water into the passenger compartment, which can cause a foul smell or a wet carpet inside the car. A warning light may show up on the dashboard.

Auto parts manufacturer has now doubled the size of its defective air bag recall.   Takata has already issued a recall for 18 million airbags.  This new recall will push that number to approximately 34 million. This is the largest auto recall in human history.  Actually, it is probably the largest recall of anything in history.

Did you watch Game of Thrones last night?  The last scene with Sansa and Ramsey was inevitable, right?  This recall was even more predictable.  Everyone and their mother saw this coming. Federal regulators have been pushing for this for what now seems like forever. Why didn’t they push hardshutterstock_161718986r?  I have no idea.  This has been 15 years in the making when customers first began filing complaints.  The first recall as in 2008.  The handwriting has long been on the wall.

Takata has reportely also agree to cooperate with the federal government in ongoing probes and oversight of the train wreck of an air-bag supplier.  Really, I’m not sure how they stay in business.  Who is buying their airbags?  How are they going to pay for the lawsuits that are coming, not only from victims, but from car makers?

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051413_Force_popUpBanner_grey_oFitbit, makes of a very cool product that tracks you activity level by counting your steps  has announced the call of their Fitbit Force wrist band, affecting almost 1 million units in the U.S., and another 28,000 units in Canada.  The problem?  Rashes.  Approximately 1.7% of Force users reported cases of skin rashes after wearing the device.

The Force, a silicon wristband pedometer, was released in October 2013.  The wireless device contained a small display and sensors for measuring motion, and tracked the wearer’s number of steps, calories burned, distance traveled, and sleep patterns.  The device then syncs the information to a computer or smartphone.

The company first acknowledged complaints last month and offered a full refund or replacement tracker to anyone who experienced skin irritation.  It is believed that some users have allergic reactions to the stainless steel casing, materials used in the strap, or adhesives used to assemble the product.  The reaction results in redness, rashes, or blistering where the skin has been in contact with the tracker.  The company has received about 9,900 reports of the wristband causing skin irritation and about 250 reports of blistering. Continue reading

The date code range is the first 6 numbers of the serial number

The date code range is the first 6 numbers of the serial number

The recall previously announced for the Series 503 Flushmate III Pressure Assist Flushing System has been expanded, affecting approximately an additional 351,000 systems.  This post discusses this recall and talks about how the jury is still out on whether a product is effective and safe even if is has been on the market for many years as these products were. Continue reading