The pharma company announced this week that large quantities of Tylenol Cold Multi-Symptom Nighttime Rapid Release Gelcaps, Tylenol Cold Multi-Symptom Rapid Release Day/Night 12+8 Gelcaps, and Tylenol Cold Multi-Symptom Rapid Release Day/Night 36+24 Gelcaps would be immediately taken off retail and wholesale shelves.  The “precautionary” recall was deemed necessary after product sample monitoring revealed elevated levels of Chlorpheniramine Ammonio Acetate (CPAA), a compound contained in some Tylenol Cold Multi-Symptom Nighttime Rapid Release Gelcaps.  

CPAA is formed from the combination of two ingredients in the medication. While certain levels of the compound are to be expected, an elevated level is not acceptable.

This is just the latest in a number of recalls involving Johnson & Johnson Tylenol products in the last year. Many of the more recent Tylenol recalls had been initiated after their packaging was found to have a musty, moldy odor that was linked to the presence of trace amounts of a chemical known as 2,4,6-tribromoanisole (TBA).    

In addition to the recent string of Tylenol recalls, the acetaminophen medication has also been linked to cases of serious liver damage in some patients who accidentally overdose. In these cases, there was often an increased risk of suffering catastrophic liver damages, including liver failure.

If you, your child, or a loved one has suffered an accidental acetaminophen overdose triggered by the use of a Tylenol product that has led to liver failure, speak to one of our acetaminophen lawyers to see if you may have grounds for a Tylenol liver damage lawsuit.

The dosage reductions, which will begin taking place this fall, will recommend on all Extra Strength Tylenol bottles that users only take a maximum of six pills (containing 3,000 mg of acetaminophen) every day. The current maximum dosage listed on bottles recommends eight pills (or 4,000 mg of acetaminophen) every day.

Additionally, J&J also announced that McNeil would also lower the maximum daily dosage for its Regular Strength Tylenol products, as well as “other adult acetaminophen-containing products,” in 2012. However, the company did not provide any additional specifics at this time.

“Some people accidentally exceed the recommended dose when taking multiple products at the same time, often without realizing they contain acetaminophen or by not reading and following the dosing instruction,” Dr. Edwin Kuffner, the vice president of OTC Medical Affairs and Clinical Research at McNeil, said following the announcement. “McNeil is revising its labels for products containing acetaminophen in an attempt to decrease the likelihood of accidental overdosing in those instances.”

While their move is undoubtedly a step in the right direction, it’s hard not to see their decision to reduce the acetaminophen dosage as an admission that their product has been harmful to its customers. Hopefully the move will cut into the 56,000 Americans who suffer liver failure from acetaminophen overdoses every year.

Dr. William M. Lee, a professor at University of Texas Southwestern Medical Center at Dallas, told ABC News that Johnson & Johnson had taken “a prudent first step” towards finally protecting its customers from acetaminophen overdoses, which can cause serious damage to the liver, including liver failure.

“Industry is coming around,” Lee said. “But there’s still a big problem. Lots of people are still overdosing.”

If you, your child, or a loved one has suffered an accidental acetaminophen overdose triggered by the use of a Tylenol product that has led to liver failure, speak to one of our acetaminophen lawyers to see if you may have grounds for a Tylenol liver damage lawsuit.

Last month, McNeil Consumer Healthcare announced that it would be voluntarily recalling 60,912 bottles of 225-pill-count Tylenol Extra Strength Caplets. It was not announced how many bottles from the affected lot, which was manufactured in February, 2009, are still on the market.

As has been the case with a number of recent recalls initiated by Tylenol’s manufacturer, the recall was announced after reports of an “uncharacteristic, musty, moldy odor” emanating from some of the bottles. The odor has been linked to the presence of 2,4,6-tribromoanisole, a chemical that McNeil/Johnson & Johnson formerly used to treat wood pellets that were used for shipping.

This is not the first recall to be announced due to musty odor caused by the chemical. In March, 34,056 bottles of Tylenol 8-Hour Extended Release Caplets that were produced at a Fort Washington, PA plant were ordered off the shelves immediately due to the musty odor.

In addition to any dangers related to the musty odor that prompted the latest recall, acetaminophen products have been found to pose a serious health risk to the liver if too much is accidentally ingested. If you, your child, or a loved one was harmed by acetaminophen, there are acetaminophen lawyers who may be able to help.

This month, Ortho-McNeil-Janssen Pharmaceuticals announced that it had recalled an entire lot of Risperdal® (risperidone) 3mg tablets from the market after learning that an “uncharacteristic odor” had been reported in some bottles.

“[We conducted an investigation that] revealed that some of the wooden pallets used by one of our suppliers in its warehouse were contaminated with TBA,” read a statement from the pharma company.  “In addition, some of the packaging components manufactured by our supplier were exposed to these pallets.”

The smell was likely caused by 2,4,6 tribromoanisole (TBA), a chemical preservative that is used to treat wood pellets that many Johnson & Johnson products used to be transported in. After initial reports of the musty odor, the company began taking steps to stop using the pellets in January.

The recall applies to the lot containing 40,000 bottles total; 16,000 Risperdal 3mg Bottles of 60 Tablets that expire in May 2012 and 24,000 Risperidone 2mg Bottles of 60 Tablets that expire in August 2012. The company believes there are currently 1,600 bottles of Risperdal and fewer than 1,200 bottles of risperidone from this lot remaining in the marketplace. 

Risperdal is used either alone or with other medications to treat schizophrenia and short-term bipolar mania in children and adults, as well as irritability associated with autistic disorder in children and adolescents ages 5-16 years.

Recalls have become a somewhat regular occurrence for J&J in the last year, as the company has had to deal with issues regarding a number of their products. In addition to its odor problems, its acetaminophen medication Tylenol has been linked as a cause of serious liver damage in certain situations. Especially when a patient accidentally overdoses on the acetaminophen product, increased risk of catastrophic liver injuries have been documented

If you, your child, or a loved one was harmed by acetaminophen, we have acetaminophen lawyers at Sokolove Law who may be able to help.

According to Reuters, a research team from the Fred Hutchison Cancer Research Center in Seattle conducted a study in which 65,000 men and women with no history of cancer in their family except for skin cancer diagnoses and a willingness to share what analgesics they had used in the last ten years had their medical history followed.

The study found that 577 people – less than one percent of the group – eventually developed some type of hematologic (blood) cancer. Of those who did develop a cancer, nine percent reported that they regularly used acetaminophen. Comparatively, only five percent of the group that did not get sick said they used similar amounts of acetaminophen.

The study found that no other analgesics such as aspirin or ibuprofen showed a similar link to increased risk of developing blood cancers.

“A person who is age 50 or older has about a 1 percent risk in ten years of getting one of these cancers,” Emily White, a member o the research team, told Reuters. “Our study suggests that if you use acetaminophen at least four times a week for at least four years, that would increase the risk to about 2 percent.”

In addition to this new link between acetaminophen and blood cancer, it has already been well documented that an acetaminophen overdose triggered by the use of Tylenol can lead to serious injuries to one’s liver. If you, or a loved one, have been harmed by acetaminophen in any way, we have an acetaminophen lawyer who may be able to help.

The recall was announced on April 14 with cooperation from the U.S. Food and Drug Administration, and applies to two lots of Topamax (topiramate) 100mg tablets that were shipped between October 19 and December 28, 2010. The lots combined to total approximately 57,000 bottles of Topamax, McNeil believes that less than 6,000 bottles are still on store shelves.

Similar to the Tylenol recall, the Topamax in question was recalled after reports of a musty odor in the packaging. The odor has since been linked to TBA (2,4,6 tribromoanisole), a chemical preservative used to treat wood pallets that are used to transport and store cases of J&J shipments and may have contaminated the lots.

Topamax is one example of a J&J medication that, while effective in treating some ailments, can also have detrimental side effects. While Topamax is effective as an anti-seizure medication for adults, it has been linked to an increased risk of pregnant women giving birth to children with oral birth defects such as cleft lip and cleft palate.

Similarly, while Tylenol has proven to be an effective pain reliever, it has been shown to cause serious liver damage in individuals who exceed the recommended dosage and suffer an acetaminophen overdose. If you, your child, or a loved one was harmed by acetaminophen, there are acetaminophen lawyers who may be able to help.

According to the U.S. Dept. of Justice, Johnson & Johnson agreed earlier to month to pay a $70 million penalty for violating the Foreign Corrupt Practices Act by bribing doctors overseas. Following an investigation – which J&J fully cooperated with – the DOJ found that certain J&J subsidiaries had given money to publicly-employed health care providers in Greece, Poland and Romania if they promised to purchase, use, or recommend the use of J&J medications and devices.

The investigation also uncovered that the money exchanges were not being done behind the back of J&J executives, and that they had actually known about them for years. In fact, the New York Times found that a criminal complaint filed with the DOJ included estimates from J&J that they could lose up to 95 percent of their business if the payments stopped.

The DOJ also announced that J&J had agreed to pay a penalty to the Securities and Exchange Commission for disgorgement of profits and pre-judgment interest.

In addition to these bribery charges, Johnson & Johnson also must deal with continued repercussions from Tylenol, which can cause catastrophic damage to the liver in the event of an overdose.  If you or a loved one was harmed by acetaminophen, there are acetaminophen lawyers who may be able to help.

J&J’s McNeil Healthcare unit announced Tuesday that more than 34,000 bottles of Tylenol 8-Hour Extended Release Caplets were being recalled because of the odor. The odor has been linked in the past to a chemical that is used to treat wooden pallets that the pharma giant used to use while shipping its products. The Tylenol products in question were also produced at a Fort Washington, PA plant that closed last April.

J&J also announced a recall of 47 million packets of Tylenol, Benadryl, Sudafed and Rolaids that was initially announced in January was being expanded, with another 717,000 packets being taken off store shelves this week.

In addition to any dangers related to the musty odor that prompted the latest recall, acetaminophen products have been found to pose a serious health risk to the liver if too much is accidentally ingested. If you, your child, or a loved one was harmed by acetaminophen, we have acetaminophen lawyers who may be able to help.

Initiated by Qualitest Pharmaceuticals (and with the knowledge of the FDA) on February 5, the voluntary recall affects three lots of Hydrocodone Bitartrate and Acetaminophen Tablets, as well as three lots of Phenobarbital Tablets. The affected lots for both pills were distributed between September 21 and December 29, 2010.

Qualitest initiated the recall after an individual bottle of the Hydrocodone Bitartrate and Acetaminophen Tablets was found incorrectly labeled with a Phenobarbital tablets label. While no mishaps were reported at the time of the recall, the mislabeling led to worries that patients may accidentally take the hydrocodone/acetaminophen pills thinking it was Phenobarbital.

If the acetaminophen pills were taken along with other medications that also contain the drug, there would likely be an increased risk of developing liver toxicity or an accidental overdose. Many over-the-counter pain relievers such as Tylenol contain acetaminophen.

If you, your child, or a loved one was harmed by an accidental acetaminophen overdose, we have acetaminophen lawyers who may be able to help.

Using data from the Centers for Disease Control and Prevention, the American Academy of Pediatrics, and other medical officials, a recent article in the South Florida-based Sun Sentinel offers advice to parents on which medications to use – and which to avoid – for their children. Among the suggestions to parents is a warning to not give their children different cough and cold medications at the same time, as doing so can increase the risk of an accidental overdose.

“They will give kids two different products with the same drug, which can be dangerous,” said Dr. Ian Paul, an associate professor of pediatrics at Penn State College of Medicine, according to the Sentinel.

Acetaminophen – a drug that is included in a number of children’s cough and cold products, including Tylenol – can cause permanent damage to the liver if one accidentally overdoses from it. If you were harmed by Tylenol or acetaminophen, our acetaminophen lawyers may be able to help.