Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., announced it is voluntarily recalling two lots of TOPAMAX 100mg Tablets.

These two lots were shipped and distributed in the U.S. and Puerto Rico.

While the recall encompasses approximately 57,000 bottles of TOPAMAX, the company believes there are fewer than 6,000 bottles remaining in the marketplace. The recall stems from four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA.

TBA, a chemical preservative sometimes applied to wood often used in the construction of pallets on which products are transported and stored. An internal investigation is underway to evaluate the potential source of this TBA issue.

In addition, the company is working with peer companies to better understand how and where TBA is entering and impacting the supply chains and what can be done to further mitigate this exposure.

Terbutaline is a drug often given to pregnant mothers to delay delivery.

When it is given during the gestation period, it can cause certain transmitters in the brain to become over stimulated. This excessive stimulation can result in a condition called nueroinflammation, which can be very damaging to the brains’ development.

The neuroinflammation can be enough to scare a family but what if terbutaline made your child more susceptible to environmental pollutants so that simple raw foods like fruits and veggies from the grocery store made them ill?

Researchers found that Terbutaline may contribute to autism spectrum disorder by making the brain abnormally venerable to environmental pollutants and pesticides.

While the actual cause of autism is unknown, many researchers believe the environment’s negative factors contribute immensely.

Educating yourself on the risks and benefits of terbutaline or any other substance can change the outcome of your child health.

For the better part of a decade, a factory in Puerto Rico produced potentially faulty and contaminated drugs for British drug maker GlaxoSmithKline.

This week, the drug maker said that it has reached a $40.75 million settlement with 37 states and the District of Columbia under their consumer protection laws following a $750 million criminal and civil settlement with the federal government last October.

Both settlements involve manufacture of substandard medicines made from 2001 through 2004 at a factory in Cidra, Puerto Rico. The poorly manufactured drugs include included Paxil CR, a blockbuster antidepressant that has since gotten generic competition, plus anti-infection ointment Bactroban, sterile anti-nausea medication Kytril and Avandamet, a diabetes drug.

The case was brought after a company whistleblower reported on conditions in the factory to the Food and Drug Administration. The whistle-blower had already reported many other violations to her bosses, including a contaminated water system and an air system that allowed for cross-contamination between different products being made there. She said she was fired in 2003 after repeatedly reporting the problems to the company.

GlaxoSmithKline admitted no wrongdoing.

Products made at the Puerto Rico plant have all been recalled or are past their expiration dates.

Source: the Associated Press

Manufacturing problems dogging Johnson & Johnson since 2009 still have not been solved. The company announced yet another drug recall because of musty odors — this time involving branded and generic forms of risperidone, the antipsychotic drug.

MedPage Today is reporting that the company’s Ortho-McNeil-Janssen subsidiary voluntarily recalled certain lost of the drug. The recall is for one lot of 3 mg Risperdal in 60-tablet bottles, lot number 0GG904, expiration May 2012, and of one lot of generic risperidone in a 2 mg dosage, lot number OIG175, sold by Patriot Pharmaceuticals.

As with several previous recalls — including the Tylenol brand of acetaminophen, Benadryl allergy medications, and topiramate (Topamax) — the company said in a statement that it had received reports from patients that the risperidone products emitted “an uncharacteristic odor.”

The two affected lots total about 40,000 bottles of risperidone.

The company advised patients with medications from these lots not to stop taking the medication. However, if they notice unusual odors, they should return the tablets to their pharmacist.

The odor in all these recalls appears to stem from a chemical preservative, 2,4,6-tribromoanisole (TBA), in wooden pallets used in shipment and storage.

No serious adverse events have been reported with the affected risperidone lots. However, according to Ortho-McNeil-Janssen, “a very small number of patients have reported temporary gastrointestinal symptoms when taking other products with this odor.”

Source: John Gever, MedPage Today

The Food and Drug Administration doesn’t try to find out whether or not medical-device recalls are successful.

Referring to a report by the Government Accountability Office,  The Hill reports that the FDA doesn’t have clear policies in place to determine whether a recall worked and doesn’t analyze individual recalls in search of more fundamental problems, the GAO said.

According to the GAO report, the FDA doesn’t have criteria for measuring whether manufacturers actually pull every defective device during recalls. Agency officials sometimes disagree about whether similar recalls have worked, the report says.

The agency also does not document its reasons for determining that recalls are complete.

Johnson & Johnson’s troubles just get more and more stinky.

According to CNN, the pharmaceutical giant announced on Thursday a recall of 57,000 bottles of the prescription anti-seizure medication Topamax following consumer complaints of an “uncharacteristic odor.”
Johnson & Johnson said the recall represents two lots of the Topamax 100 mg tablets made by its Ortho-McNeil Neurologics division.

The affected drugs were shipped and distributed between Oct. 19, 2010 and Dec. 28, 2010 in the United States and Puerto Rico.

The company said it believes fewer than 6,000 bottles of the medicine remain in the marketplace to be recalled. However, Ortho-McNeil Neurologics said it does not anticipate a product shortage resulting from the recall.

J&J said it initiated the recall after receiving four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole).

The drug is already under fire because it has been linked to oral birth defects in infants who were exposed when their mothers took it.

Last month, the government announced it was taking over three Tylenol plants operated by McNeil following a wave of drug recalls and a Food and Drug Administration criminal investigation into safety issues at the factories.

While not considered to be toxic, J&J said TBA can generate an offensive odor, and a very small number of patients have reported temporary gastrointestinal symptoms.

Source: CNN Money

After more than 50 product recalls in 15 months, including for artificial hips and Tylenol, the $60 billion company is fighting to clear its once-trusted name.

The recalls — voluntary and otherwise — reads like your family medicine cabinet: Tylenol and St. Joseph Aspirin were recalled for foul odors people said made them sick; Benadryl and Zyrtec were recalled for botched amounts of ingredients; Rolaids were recalled for containing bits of wood and metal.

Over the last 15 months, the company has recalled contact lenses, syringes filled with prescription medications, hernia devices, and other products made by subsidiaries around the world.

In the year ended Mar. 8, 2011, J&J was involved in at least 11 major recalls, as defined by the FDA, almost twice as many as Pfizer (PFE), the world’s largest health-care-products company by revenue, or Procter & Gamble (PG), the world’s largest consumer-products company.

J&J’s woes aren’t confined to the last couple of years. During the last decade, the company has been repeatedly confronted with claims that it sold a product that was defective, or that carried risks J&J downplayed in its marketing. It has been accused of paying kickbacks and using other financial incentives to promote off-label use of drugs and devices. It has been cited by federal authorities for trying to avoid the publicity of a recall by quietly buying up tainted products. And it frustrated FDA regulators who were urging the company to strengthen quality control at the factories that produced many of the recalled over-the-counter products.

J&J has steadfastly denied these claims, but its own annual report for 2010 contains eight pages detailing government criminal and civil investigations and thousands of private lawsuits covering a wide range of drugs, devices, and business practices.

If you’ve haven’t been keeping up, here is a recap of the recalls in just the last couple of years.

Johnson & Johnson’s recall rap sheet:

• AUG 2008: Consultants to J&J buy defective Motrin from stores. The FDA says it wasn’t notified of this “phantom recall.”
• NOV 2009: McNeil pulls about 6.3 million bottles of tainted Tylenol Arthritis Pain caplets made in Puerto Rico.
• JAN 2010: McNeil expands withdrawal to include Benadryl Allergy, Tylenol, Children’s Tylenol Meltaway, and Rolaids.
• APR 2010: J&J recalls 135 million bottles of meds made in Fort Washington, Pa., and closes the plant.
• MAY 2010: The FDA says the U.S. may pursue criminal charges against J&J.
• JUNE 2010: McNeil expands the recall from its Puerto Rico plant to include five more lots of Benadryl and Tylenol.
• JULY 2010: Yet more recalls; company submits remediation plan for McNeil plants to FDA.
• AUG 2010: Company appoints quality-control czar, announces corporation-wide standards.
• AUG 2010: J&J pulls 100,000 boxes of 1-Day Acuvue TruEye contact lenses; days later, DePuy recalls ASR hips.
• DEC 2010: 13 million packages of Rolaids softchews are recalled after customers find wood and metal particles in them.
• JAN 2011: J&J withdraws 43 million bottles of Rolaids, Tylenol, Benadryl, and Sinutab.
• JAN 2011: J&J announces 2010 earnings, puts lost sales from recalls and plant slowdowns at $900 million.
• FEB 2011: J&J units announce recalls of 70,000 potentially cracked syringes preloaded with the antipsychotic Invega.
• MAR 2011: J&J withdraws 585,000 surgical sutures due to concerns about compromised sterile packaging.
• MAR 2011: J&J’s Animas unit announces recall of 384,000 insulin-pump cartridges that may leak.
• MAR 2011: FDA and McNeil announce consent decree that will give agency expanded oversight of three plants.

Each year hundreds of thousands of Americans undergo elective hip replacement surgery. For the most part, few patients regret undergoing this surgery which reduces pain and increases their mobility.

Most of the prosthetic devices used are safe, however, through the years various orthopedic medical devices, such as prosthetic knees and prosthetic hips have been associated with complications.

DePuy Orthopaedics, a subsidiary of Johnson & Johnson is the latest manufacturer to recall a defective medical device.

On August 24, 2010 DePuy voluntarily recalled ASR XL Acetabular Hip System and DePuy ASR Hip Resurfacing System Implant products sold after 2006. It is estimated that 1 in 8 patients will suffer from complications. As a result medical monitoring including blood tests and X-rays may be necessary especially if a patient is experiencing pain or difficulty walking.

DePuy customers should avoid any discussions with company representatives since it may compromise their legal rights. There are many complex issues pertaining to the valuation of past, present and future pain and suffering; issues regarding the cost of ongoing medical monitoring and future revision surgery; as well as the potential reimbursement of medical claims by Medicare and other insurance company interests.

Before speaking with any representative it is advised to contact a lawyer skilled in medical device litigation.

All DePuy implant customers should speak to a lawyer to gain a full understanding of their rights concerning a problem which may last decades and should be leery of signing any documents or authorizations before consulting with lawyers.

An earlier Class I recall of saline flush syringes has now prompted a secondary FDA recall of venous catheter trays that included the defective syringes.

Cook Inc., of Bloomington, Ind., has issued an urgent recall for a series of defective central venous catheter trays, including single, double, triple, and five-lumen trays as well as single and double lumen PICC peripheral inserted central venous catheter trays.

The original Class I recall, announced in October 2010, involved certain lots of 6-mL prefilled saline flush syringes (0.9 percent sodium chloride) manufactured by Excelsior Medical Inc.

Leaks in the plunger luer were detected during a routine syringe leak test. The potential exists for leakage and possible loss of sterility.

After learning of the problem with this defective medical device, Cook initiated its own Class I recall. This class of recall means the affected products pose a risk of serious injury or death.

The recalled defective medical devices include 123 individual catheter products, which come packaged in trays containing different sizes. The catheters are used to monitor a patient’s pressure in a vein, for blood sampling, and administration of drugs and fluids.

Source: John Gever, Senior Editor, MedPage Today

A judge accepted a guilty plea by a division of Boston Scientific on charges that it hid defects in heart defibrillators. In addition, the judge  placed the company on three years’ probation.