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An investigation of the Motrin tablets, which didn’t dissolve properly, is being conducted by the House Oversight and Government Reform Committee as part of an inquiry into children’s Tylenol and other medicines recalled on April 30 by McNeil because of manufacturing defects. During a Committee hearing last month, it was learned that McNeil hired contractors to buy Motrin IB caplets under orders not to mention the term “recall” after learning in November 2008 that the drugs were not dissolving properly. A memo titled “Motrin Purchase Project” instructed the contractors to “on your schedule to locate and purchase” all of the Motrin eight-count packages. The document further instructed them to “‘act’ like a regular customer in making these.

McNeil finally recalled 88,000 packages of the drug in July 2009 after the federal regulators learned of the purchase effort. Since learning of the incident, Chairman of the House Oversight and Government Reform Committee, Edolphus Towns (D-NY), has referred to the Motrin purchase effort as a “phantom recall.”

Bloomberg News obtained copies of emails from a source close to the investigation that show Peter Luther, president of McNeil since 2009, told employees to go ahead with what he termed a “market withdraw of Motrin." “Let’s make this happen ASAP," he wrote.

A May 2009 email from Luther to six McNeil employees also showed that he had some concerns about the costs of the effort. “Given our current financial situation, I hope we’re not going to really double our cost to do this," he wrote.

At the Oversight Committee's May 27 hearing, Colleen Goggins, Johnson & Johnson’s consumer group chairman, insisted the company hadn’t intended to mislead anyone about the Motrin incident. In a phone interview with Bloomberg, she continued to maintain that the Food & Drug Administration (FDA) was fully informed of the effort.

An FDA spokesperson told Bloomberg via email that McNeil only informed the FDA it would “sample” from stores where the Motrin had been sent, not that contractors would ‘act like a regular customer,’ and buy all of the product in question.

But Bloomberg's source said that Luther's emails show that senior McNeil executives were involved with the plan to buy back the defective Motrin in large quantities, and that contractors weren't merely performing a sampling to determine whether the product made it into stores.

During a hearing into recent recalls of children's Tylenol and other medicines by Johnson & Johnson's McNeil Consumer Healthcare unit conducted by the House Oversight and Government Reform Committee last month, it was learned that McNeil hired contractors to buy Motrin IB caplets under orders not to mention the term “recall” after learning in November 2008 that the drugs were not dissolving properly. A memo titled “Motrin Purchase Project” instructed the contractors to “on your schedule to locate and purchase” all of the Motrin eight-count packages. The document further instructed them to “‘act’ like a regular customer in making these purchases.” Neither the public nor the U.S. Food & Drug Administration (FDA) was informed of the action.

McNeil finally recalled 88,000 packages of the drug in July 2009 after the FDA learned of the purchase effort. Since learning of the incident, Chairman of the House Oversight and Government Reform Committee, Edolphus Towns (D-NY), has referred to the Motrin purchase effort as a “phantom recall.”

Now, The Wall Street Journal is reporting that internal Johnson & Johnson emails show that some employees knew of the buyback effort. The emails were exchanged last spring between Johnson & Johnson personnel and Inmar Inc. a Winston-Salem, N.C. firm that specializes in product retrievals.

In one email, dated April 1, 2009, an Inmar official tells four Johnson & Johnson employees that contractors would tell stores their purchases "random quality and/or packaging checks"or are "purchasing some samples." The memo to contract workers was sent from an entity called "WIS" that was working for a client called "CSCS" on behalf of Johnson & Johnson, the Journal said. The report noted that Inmar has a division called CSCS.

Johnson & Johnson has been under scrutiny since April, when McNeil Consumer Healthcare recalled more than 40 varieties of Tylenol Infant Drops, Children’s Tylenol Suspensions, Children’s Tylenol Plus Suspensions, Motrin Infant Drops, Children’s Motrin Suspensions, Children’s Zyrtec Liquid in Bottles, and Children’s Benadryl Allergy Liquid.

McNeil has temporarily shut down production at the Fort Washington, PA facility that made the drugs. In April, the FDA cited more than 20 manufacturing problems, including not properly testing for contamination of the recalled products. The problems prompted the FDA to widen its investigation of McNeil’s manufacturing practices, and it is now inspecting the company’s other facilities in Lancaster, PA and Puerto Rico. Officials from the agency have also said they were considering possible criminal charges against Johnson & Johnson and McNeil.

J&J removed the questionable OTC products from store shelves in what Congressional staff described as “the largest recall of children's medicine in the history of the U.S. Food & Drug Administration (FDA)," quoted Reuters from a May 24 memo to committee lawmakers. Now, Reuters reports that the FDA has received over 700 complaints about adverse reactions in children and infants given J&J medications. The reports include 30 deaths. Direct links have not yet been made with to J&J drugs, said Reuters citing a Congressional memo.

Recently, we wrote that the Wall Street Journal obtained a copy of a letter McNeil sent to doctors and poison control centers on May 1 providing information about the recall in which it said that some samples of recalled infants’ Tylenol were found to contain as much as 24% more active ingredient than shown on the label. Also, the Journal recently published new details about McNeil Consumer Healthcare’s recent recall of over-the-counter (OTC) medicines. Much of what the Journal reports is disturbing.

Meanwhile, members of the House Oversight and Government Reform Committee released details of the FDA’s investigation this week and a U.S. House of Representatives hearing to review the manufacturing issues at J&J plants that led to the recall is scheduled for today, said Reuters. The FDA is investigating manufacturing procedures at the Fort Washington, PA manufacturing facility where the recalled medicines were made and is also investigating McNeil’s manufacturing company wide. McNeil also makes drugs at plants in Lancaster, PA, and Las Piedras, Puerto Rico. Since the recall, the Fort Washington plant has been closed until McNeil can assure quality production and the FDA clears the site.

Written testimony, authored by Joshua Sharfstein, the FDA's principal deputy commissioner and prepared for today’s House committee meeting discussed the broad recall and said the agency is working with the firm “to address its systemic quality issues,” quoted the Journal. "FDA is also considering additional enforcement actions against the company for its pattern of noncompliance which may include seizure, injunction, or criminal penalties," Mr. Sharfstein said, wrote the Journal. "Over the last several years, FDA has had growing concerns about the quality of the company's manufacturing process," Sharfstein added.

According to Reuters, FDA inspectors found a variety of problems at the plant in late April, such as “bacterial contamination of ingredients and filthy equipment … some medications … were overly concentrated and ‘had the potential to be superpotent,’ citing the Congressional memo. The Journal noted that the bacterial contamination was found in a raw ingredient used to manufacturer Tylenol and another problem resulted in some drugs to have higher levels of active ingredients while some products contained metallic particles.

The recall includes more than 40 varieties of Tylenol Infant Drops, Children's Tylenol Suspensions, Children's Tylenol Plus Suspensions, Motrin Infant Drops, Children's Motrin Suspensions, Children's Zyrtec Liquid in Bottles, and Children's Benadryl Allergy Liquid in Bottles. A complete list of recalled products is available here.

In addition to the U.S., the recall is taking place in 11 other countries. These include: Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait.

Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While the potential for serious medical events is remote, consumers who have purchased these recalled products are advised to discontinue use.

According to a press release from McNeil, this recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these products to their children.

The U.S. Food & Drug Administration (FDA) is recommending that consumers use other products on the market, including generic versions of the recalled products, which are intended for use in infants and children and are not affected by the recall. The agency said it does not anticipate that there will be a shortage of alternative products.

All of the recalled drugs were made at a factory in Fort Washington, PA. The FDA said it was reviewing procedures at McNeil, which appears to be the sole source of the problems. For its part, McNeil said it is conducting a comprehensive quality assessment across its manufacturing operations and has identified corrective actions that will be implemented before new manufacturing is initiated at the plant where the recalled products were made.

According to McNeil, consumer complaints about some of the recalled medications prompted an internal review at the Pennsylvania facility. That in turn led to the recall.

This is not the first time McNeil has pulled over-the-counter products from store shelves because of consume complaints. Last November, the company recalled 5 lots of Tylenol Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP following consumer reports of a musty odor, which was associated with nausea, stomach pain, vomiting and diarrhea.

That recall was expanded in December to include all lots of the Tylenol Arthritis Pain Caplets. Then in January, the list of recalled drugs was expanded yet again to include various lot of Tylenol, Rolaids, Benedryl and St. Joseph’s Aspirin. In total, the expanded recall included about 50 million bottles of the medications.

Last November, Johnson & Johnson’s McNeil Consumer Healthcare unit recalled 5 lots of Tylenol Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP because of reports of the odor, which was associated with nausea, stomach pain, vomiting and diarrhea. That recall was expanded in December to include all lots of the product.

At the time, McNeil said the uncharacteristic smell associated with recalled Tylenol Arthritis Pain Caplets was caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole. The source of 2,4,6-tribromoanisole is believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials. The health effects of this compound have not been well studied, but McNeil said that so far, to date all of the reported adverse reactions have been temporary and non-serious.

Now, McNeil is recalling more products that might be tainted with the same chemical. In addition to pain relievers Motrin and Tylenol, and the Rolaids antacid, the recall also involved the Benadryl allergy drug and St. Joseph's Aspirin. The recall involves lots in the Americas, the United Arab Emirates (UAE), and Fiji. A complete list of recalled products is available here, or call 1-888-222-6036 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time).

Since the December recall, the company said it has now applied broader criteria to identify and remove all product lots that may be affected, even if they have not been the subject of consumer complaints. McNeil also said it was ceasing shipment of products produced using materials shipped on the wood pallets and requiring suppliers to stop using the pallets.

McNeil has not been able to determine how the chemical may have penetrated product packaging.

Stevens-Johnson Syndrome is a sometimes life-threatening hypersensitivity complex affecting the skin and the mucous membrane that may be caused by many drugs, viral infections, and malignancies. Steven-Johnson Syndrome is characterized by blistering of mucous membranes, typically in the mouth, eyes, and vagina, and patchy areas of rash. It can cause the top layer of the skin to separate from the lower layer of the skin in affected areas. � Stevens-Johnson Syndrome is fatal in about 5 percent of all cases.

Because it involves the mucus membrane, Stevens-Johnson Syndrome usually requires treatment in a hospital burn unit. � A recent New York study linked ibuprofen to nearly half of the 32 children referred to a local burn unit over an eight-year period.

The parents of Sabrina Johnson, who was six at the time of her diagnosis, said she was given two doses - one in the afternoon and another later in the evening - of Children's Motrin one day in 2003 to alleviate symptoms of a fever. � According to the lawsuit, Sabrina awoke the next morning with a high fever, her eyes were pink, and her mouth was swollen and covered in sores. � Sabrina was immediately hospitalized, but by the next day, she was blind in both eyes. Doctors then diagnosed Stevens-Johnson Syndrome.

Sabrina's lawyer alleges that Johnson & Johnson knew of a link between ibuprofen, the active ingredient in Motrin, and Stevens-Johnson Syndrome. The lawsuit points out that while the prescription version of the drug has stronger warnings, the over-the-counter version mentions nothing about this risk.

Jury selection for Sabrina's lawsuit, which is being heard in Los Angeles Superior Court, began last week. Arguments are expected to begin � this � week. � Sabrina's Stevens-Johnson Syndrome lawsuit is the first of nine similar lawsuits scheduled to begin this year and next in the US.