Can You Believe It? J&J Announces Another Recall...

McNeil Consumer Healthcare Initiates Yet Another Voluntary Recall Of Certain Products.

Just when you thought it could not get much worse for J &J, on Friday Johnson & Johnson’s McNeil Consumer Healthcare Division, in consultation with the U.S. Food and Drug Administration recalled certain lots of TYLENOL® 8 Hour, TYLENOL® Arthritis Pain, and TYLENOL® upper respiratory products, and certain lots of BENADRYL®, SUDAFED PE®, and SINUTAB® products distributed in the United States, the Caribbean, and Brazil.

The J &J company statement said that the recalled products were manufactured at the McNeil plant in Fort Washington, Pennsylvania prior to April 2010, when production at the facility was suspended. The company is initiating the recall as a precautionary measure after an extensive review of past production records found instances where equipment cleaning procedures were insufficient or that cleaning was not adequately documented. It is very unlikely that this impacted the quality of these products.

In addition, McNeil Consumer Healthcare is also initiating a voluntary recall of certain product lots of ROLAIDS® Multi-Symptom Berry Tablets distributed in the United States, in order to update the labeling. The company initiated the recall after determining that the product labeling does not include the language “Does not meet USP” as required by regulation.

According to the press release, McNeil identified the inadequacies as part of a thorough, proactive product quality and process assessment of all McNeil produced products.

On all levels this is a saga of an industry giant that has poorly managed the entire process of production, product quality control, regulatory affairs and public relations. J&J’s entire corporate image, trusted brands, executive management and financial future is in a significant state of decline.

J&J’s announcement of a comprehensive plan to clean up its production and public image is a operational and PR process that should have been initiated many months ago.

The lost sales, enormous expense in recalls and cost to the brands has to be a huge hit to J&J's bottom line.

This story is a cautionary tale for all, not making an investment in and failure to take the necessary steps to assure quality control and to protect your brand from sub-standard production, poor quality raw materials, fraud, adulteration and counterfeit will cost the stakeholders and consumer.

What are the odds that we will see another recall from J&J soon?

To learn more about supply chain authentication technologies, visit: http://www.xstreamsystems.net/

The Recalls Keep Piling Up for J&J

McNEIL CONSUMER HEALTHCARE ANNOUNCES VOLUNTARY RECALL OF ALL LOTS OF ROLAIDS® EXTRA STRENGTH SOFTCHEWS, ROLAIDS® EXTRA STRENGTH PLUS GAS SOFTCHEWS, AND ROLAIDS® MULTI-SYMPTOM PLUS ANTI-GAS SOFTCHEWS SOLD IN THE UNITED STATES

No sooner had Secure Pharma Chain posted it blog from Pharmalot but comes more bad news from the pharmaceutical industry giant.

In a seemingly never-ending story, Johnson & Johnson’s embattled McNeil Consumer Healthcare unit has issued yet another recall, this time for its ubiquitous Rolaids brand.

It remains to be seen how many hits to its venerable brands can the industry giant take and retain its trust regarding the safety and efficacy of its respected and ever-present products with consumers.

J&J explains the recall in its press release with the following:

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. is voluntarily recalling all lots of ROLAIDS® Extra Strength Softchews, ROLAIDS® Extra Strength plus Gas Softchews, and ROLAIDS® Multi-Symptom plus Anti-Gas Softchews distributed in the United States. McNeil is taking this action following some consumer reports of foreign materials in the product, including metal and wood particles. The company’s investigation has determined that the materials were potentially introduced into the product during the manufacturing process at a third party manufacturer. While the risk of serious adverse health consequences is remote, McNeil Consumer Healthcare advises consumers who have purchased these recalled products to discontinue use.

J&J is feeling the immediate financial impact of the loss of sales, expense of recalls and operational expenses. The long term impact in liabilities, brand erosion and loss of consumer confidence will continue to accrue for many years to come.

Members of the pharmaceutical supply chain (manufacturers, distributors and dispensers) should take heed from the woes of J&J. Testing and protection of the brand and inventories from poor quality, fraud, adulteration and counterfeiting does not stop at any one point of the supply chain process. Measures must be deployed at all stops of the supply chain to test the quality and authenticate that the product being consumed is safe and efficacious.

To read the entire official J&J Press Release regarding the recall and its details, visit: http://www.rolaids.com/page.jhtml?id=rolaids/include/recall_dec.inc

To learn about supply chain authentication technologies, visit: http://www.xstreamsystems.net/

Pharmalot: The Sorry List of Johnson & Johnson Troubles

“We now see a strong likelihood of near-term FDA enforcement action.”

Once again Ed Silverman in his Pharmalot blog outlines the issues that have plagued the pharmaceutical industry giant over mandated recalls, “phantom recalls”, other regulatory misdeeds that have impacted their venerable brands including Tylenol, Mylanta, Motrin, Rolaids and Benadryl.

In his blog, Mr. Silverman cites Wells Fargo Securities analyst Larry Bigelsen regarding the potential impact of continued FDA scrutiny on their operations and to J&J stock.

This blog presents some interesting, whimsical insight into the depth of the problem and the potential impact operationally and financially to J&J.

Secure Pharma Chain sees this as a cautionary tale to the pharmaceutical supply chain- protect the production, quality, efficacy and distribution of your product and inventories within the supply chain or risk the reputation and viability with the consumer. The stakes are high and the consequences to the brand and the consumer can be lethal.

It is vital that all members of the pharmaceutical supply chain deploy and utilize technologies that protect consumers from adulterated, fraudulent, sub-standard, poor quality and counterfeit drugs.

To read the entire Pharmalot blog, visit: http://www.pharmalot.com/2010/12/the-sorry-list-of-johnson-johnson-troubles/

To learn more about pharmaceutical authentication technology, visit: http://www.xstreamsystems.net/.

Pharmalot: Another Day, Another Johnson & Johnson Recall

Ed Silverman continues his insightful and humorous blogging on yet another recall from J&J’s McNeil Consumer Health unit:

Highlighted in Mr. Silverman's blog:

• Once again, Johnson & Johnson has yanked a huge amount of over-the-counter medicines. This time, the recall involved about 4 million packages of children’s Benadryl allergy tablets and about 800,000 bottles of children’s Motrin caplets from pharmacies and distributors due to “inefficiencies” in manufacturing.

• Specifically, all product lots of Children’s Benadryl Allergy Fastmelt Tablets in cherry and grape flavors distributed in the US, Belize, Barbados, Canada, Puerto Rico, St. Martin, and St. Thomas and all product lots of Junior Strength Motrin Caplets distributed in the US. However, there was no indication of any adverse event reports or that the products “do not meet quality standards,” she wrote. Consequently, consumers can continue to use the products.

• Unlike the series of previous recalls, the health care giant did not issue a press release to announce these moves. When asked to explain the difference in procedure, the spokeswoman wrote this is considered a distributor recall, but that the info was posted on the individual product web sites on Nov. 15.

• Tens of millions of bottles have since been recalled; a plant in Fort Washington, Pa., has been shuttered and may be retrofitted; some 300 plant workers lost their jobs; Congressional hearings have been held; federal and state investigations are under way; consumer confidence in the company is falling; a quality control guru was appointed at the corporate level and at least $600 million in sales will be lost this year.

Since the posting of the Pharmalot blog, J&J has added another recall, this time of nearly 9 million bottles of Tylenol.

At some point, it seems logical that J&J would aggressively be doing everything in its power to alleviate these quality control issues.

To read the entire Pharmalot blog, visit: http://www.pharmalot.com/2010/11/another-day-another-johnson-johnson-recall/

Pharmalot: Johnson & Johnson Gets Subpoena Over Recalls

Ed Silverman in Pharmalot reports today about the most recent wrinkle of a Federal Grand Jury Subpoena in the ongoing Johnson & Johnson recall saga.

During the an earning teleconference a Johnson & Johnson exec disclosed that the US Attorney’s Office in Philadelphia sent a grand jury subpoena about the vast and ongoing recall of millions of bottles of over-the-counter pediatric medicines by J&J’s McNeil Consumer Healthcare unit.

To read the entire Pharmalot blog post and another blog post regarding new legislation mandating drug recalls, visit: http://www.pharmalot.com/

Pharmalot: J&J Fires 300 Employees Over the Tylenol Recalls

Once again Ed Silverman in his Pharmalot blog continues to maintain the best insight and commentary on the never ending J&J Recall scandal.

In a July 15th blog, Mr. Silverman reports on J&J’s recent publicly released statement which included the announcement that they will fire 300 to 400 people who work in the Fort Washington, Pennsylvania McNeil plant. This is the site and headquarters where most of the quality-control problems were found and the managerial decisions were made.

Mr. Silverman’s Pharmalot commentary included:

· The healthcare giant submitted its long-awaited remediation plan to the FDA today - you know, the plan that is supposed to help Johnson & Johnson’s McNeil Consumer Healthcare unit get back on track after recalling tens of millions of over-the-counter pediatric medicines. And in a vague statement, J&J says one way to cope is to can 300 of the 400-plus people who work at the Fort Washington, Pa., plant where most of the quality-control problems were found and managerial decisions were made.

· The employees are being let go because it’s not clear when the plant will operate again. A J&J spokeswoman says the “best estimate” is the middle of 2011. Recently, J&J acknowledged that a few hundred million dollars in sales will be lost; the average annual sales of the products made at this plant over the last three years were about $650 million, although that remains a sliver of J&J consumer sales, which last year were $4.2 billion out of $16.5 billion total sales worldwide. J&J vows to expand capacity elsewhere to compensate for the shortages.

· There was no word, however, whether any senior McNeil execs are among those being shown the door, given that the McNeil unit is headquartered in Fort Washington. Take Peter Luther, who heads the unit. He allegedly recommended a recall of Motrin pills without notifying the FDA or the public.

To read the entire Pharmalot blog, visit: http://www.pharmalot.com/2010/07/jj-fires-300-employees-over-the-tylenol-recalls/#more-24878.

As quality control issues continue to dog large branded and generic pharmaceutical companies it is vital that all members of the pharmaceutical supply chain monitor the quality and protect their inventories in order to make certain that health care consumers have access to safe and efficacious medications.

Secure Pharma Chain Blog endorses material authentication which can be deployed easily and efficiently within the supply chain to verify the authenticity and quality of medications within their unit of sale container.

To learn about material authentication solutions, visit: http://www.xstreamsystems.net/.

Johnson & Johnson, The Recalls Continue

J&J recalls more Tylenol, over-the-counter drugs, recalled lots linked to odors.

Johnson & Johnson recalled more Tylenol and other over-the-counter drugs on July 8th after the 21 lots of Tylenol, Benadryl and Motrin were linked to a musty or moldy odor. This action continues to expand a recall the company’s McNeil Consumer Healthcare unit started in January.

Johnson & Johnson’s McNeil Consumer Healthcare unit said the latest recall involved 21 lots of medications, including Tylenol for children and adults, several forms of Benadryl allergy tablets and Motrin painkiller. However J&J spokesperson Bonnie Jacobs was unable to disclose how many pieces were in each lot or give a total number of items involved.

Thursday's recall, like the one in June, was related to J&J's January recall of 53 million bottles of widely used products, which were also linked to odors.

On June 15, J&J recalled four lots of Benadryl and one lot of Extra Strength Tylenol gels.

"These lots are being added to the list of recalled products as a precautionary measure after a continuing internal review determined that some packaging materials used in the lots had been shipped and stored on the same type of wooden pallet that was tied to the presence of TBA in earlier recalled lots," Johnson & Johnson said in a press statement.

As with the previous recalls, Johnson & Johnson are encouraging consumers who have purchased the products included in the recall should stop taking them and contact the company about a refund or replacement

Not counting the subsequent follow up recalls to the January 15th recall, McNeil has issued four product recalls in the past year due to quality control problems at its plants, sparking a congressional investigation and scrutiny from the U.S. Food and Drug Administration.

Secure Pharma Chain Blog encourages all within the pharmaceutical supply chain to authenticate and verify the quality of their inventories while protecting consumers from fraud, adulteration and counterfeit product.

To learn more about pharmaceutical supply chain solutions to quality control and product authentication, visit: http://www.xstreamsystems.net/.

Pharmalot: Johnson & Johnson Was a Repeat Offender

Once again, Ed Silverman from the Pharma industry blog, Pharmalot seems to have the story on the continuing saga regarding Johnson & Johnson and the massive recalls from their McNeil Consumer Group.

In his blog Mr. Silverman provides some insight into some reports from CNN including video on their report.

According to Pharmalot:

· The recent rash of recalls, which has sullied the storied Johnson & Johnson image, actually reflects a series of production gaffes that go back several years, according to a report from CNN, which collected various FDA inspection reports by filing with Freedom of Information Act requests.
· The healthcare giant actually committed several violations that were detailed in inspection reports. Of course, companies with extensive manufacturing operations are likely to commit errors now and then, but the point CNN tries to make is that a pattern appears to exist.
· A December 2003 inspection report noted a mislabeling problem related to some lots of children’s soft-chew Tylenol; packages listed an incorrect amount of an ingredient per tablet. McNeil did not recall the affected products but destroyed and relabeled the products that had not yet been released into the market. In January 2006, FDA inspectors noted some equipment used to make drugs had not been properly cleaned. Another report from February 2008 listed insufficient follow-up and investigation of consumer complaints.

Clearly it would appear that there is a lot of past and present history that will be sorted out over the next several months as a variety of regulatory bodies, including Congress put Johnson & Johnson through their paces.

Secure Pharma Chain Blog, encourages everyone within the pharmaceutical supply chain, from manufacturer to dispenser, to deploy authentication technologies to protect their brand, inventories and the consumer from poor quality, fraud, adulteration and counterfeiting .

To read this excellent Pharmalot blog, visit: http://www.pharmalot.com/2010/06/johnson-johnson-was-a-repeat-offender/.

To learn more about pharmaceutical supply chain authentication solutions, visit: http://www.xstreamsystems.net/.

J&J Unit Recalls More OTC Drugs

Late Tuesday, Johnson & Johnson's McNeil Consumer Products division announced the inclusion of several other of its hugely popular brands to its massive OTC recall. It is now recall four lots of Benadryl allergy tablets and one specific lot of its Extra Strength Tylenol gel pills.

Including this recent recall announcement Johnson & Johnson’s McNeil Consumer Products division has issued four recalls over the past twelve months.

Various media outlets are reporting on this development:

The New York Times: "The Johnson & Johnson unit whose recall of liquid children's Tylenol and other pediatric medicines is under Congressional investigation said on Tuesday evening that it was recalling additional over-the-counter drugs." Specifically, McNeil Consumer Healthcare "said that it was recalling four lots of certain Benadryl allergy tablets and one lot of Extra Strength Tylenol gel pills." According to a company statement, "'the products were inadvertently omitted' from an earlier recall -- one preceding the children's drug recall -- involving medicines made at a company plant in Puerto Rico." Although the drugmaker maintains that the chances of experiencing serious side effects are nil, it began recalling products from the Las Piedras plant in November after consumers were reportedly overcome by a mildew-like odor.

The Wall Street Journal: The smell purportedly prompted stomach pain, diarrhea, and nausea. The unit has since identified the manufacturing issue.

Bloomberg News: "the odor has been linked to trace amounts of a chemical called 2,4,6-tribromoanisole, or TBA, found on storage pallets."

Reuters: US House of Representatives Oversight and Government Reform Committee Chairman Edolphus Towns (D-NY) said, "This latest recall is further evidence that there are wide-ranging problems at Johnson & Johnson." He added, "I am troubled by what we have learned so far in our investigation, and this latest development adds to my concern."

The recent proliferation of recalls generated from pharma manufacturers due to poor quality production, inadequate quality control, cargo theft and various other adulterations to the consumer product strengthens the concept of material authentication by all members of the pharmaceutical supply chain. Material authentication, inside the products unit-of-sale container protects the members of the suppy chains inventories and the end use consumer.

To read the various reports on this recent announcement and the J&J recall from The New York Times, Wall Street Journal, Bloomberg News and Reuters, visit these sites:

http://www.nytimes.com/2010/06/16/health/16drug.html.

http://online.wsj.com/article/SB10001424052748704009804575309132577939048.html?mod=googlenews_wsj.

http://www.bloomberg.com/apps/news?pid=20601202&sid=awltXaS.MHl4.

http://www.reuters.com/article/idUSN159754220100615.

To learn more about pharmaceutical supply chain security solutions that protect the supply chain and consumers from poor quality, fraudulent, adulterated and counterfeit drugs, visit: http://www.xstreamsystems.net/.

Johnson & Johnson Faces Possible Criminal Charges

Widely reported by most media outlets, pharmaceutical giant Johnson & Johnson and its McNeil Consumer Products division may face a variety of charges including criminal for what was described by FDA officials in a May 27th Congressional hearing as “a pattern of violations in manufacturing and quality control practices (which) led to a number of recent recalls.

The following are some of the media highlights from yesterday and today:

• ABC World News George Stephanopoulos reported, "Government officials said today they are considering criminal charges against Johnson & Johnson, stemming from last month's huge recall of Tylenol and other popular over the counter children's medicines."

• NBC Nightly News Brian Williams reported, "Johnson & Johnson insists it has taken dramatic steps to clean up the plants where the recalled products are made. Meanwhile, the FDA says it has referred the matter to its criminal division for consideration."

• The New York Times reports, "The Johnson & Johnson unit that recalled millions of bottles of liquid children's Tylenol and other pediatric medicines last month may face criminal penalties, product seizures, or other sanctions, an official from the Food and Drug Administration said Thursday." Notably, the "agency is considering further actions against McNeil Consumer Healthcare...after a pattern of violations in manufacturing and quality control practices led to a number of recent recalls," Sharfstein "said at a Congressional hearing on Thursday."

• The Washington Post states, "When faced last year with Motrin IB caplets that were not dissolving properly, McNeil Consumer Healthcare, a division of Johnson and Johnson, hired contractors to buy the products under orders not to mention the term 'recall,' according to documents released by the House Committee on Oversight and Government Reform." Then, "after the Food and Drug Administration discovered the effort -- because one of the contractors accidentally dropped an instruction sheet on the floor of a store -- McNeil announced a recall of roughly 88,000 packages of the product." And, in the last year, there have been "four recalls of McNeil products...including the April 30 recall of 136 million bottles of infant and children's Tylenol, Motrin, Benadryl and Zyrtec, which have shaken consumers' confidence and threaten to stain Johnson and Johnson's brand name."

• The Los Angeles Times reports that following the revelations at the hearing, "Colleen Goggins, chairwoman of Johnson & Johnson's consumer division, apologized 'to the mothers and fathers and caregivers for the concern and inconvenience' caused by the April recall."

Securing Pharma Chain Blog, supports the inclusion of authentication and verification of pharmaceuticals at all members of the pharmaceutical supply chain to protect against poor manufacturing practices, fraud, adulteration and counterfeiting and avoid consumption of bogus materials by consumers.

To learn more about supply chain authentication solutions, visit: http://www.xstreamsystems.net/.

To read the major media stories, visit:

http://www.nytimes.com/2010/05/28/business/28drug.html?src=busln.

http://www.washingtonpost.com/wp-dyn/content/article/2010/05/27/AR2010052705484.html?hpid=moreheadlines.

http://www.latimes.com/news/nationworld/nation/la-na-tylenol-hearing-20100528,0,1137250.story.

WSJ: J&J Details Recall Troubles

In the May 18 edition of the Wall Street Journal, Jonathon Rockoff writes about new details emerging from the problems with Johnson and Johnson’s production and recall of certain children's medicines. These details are coming forward as the company faces growing scrutiny in Washington, D.C.

Many of the details were obtained via a letter, dated May 1st from Johnson and Johnson to doctors and poison control officials.

Here are some of the highlights from the article:

· Some samples of recalled infants' Tylenol were tested to contain as much as 24% more active ingredient than shown on the label, according to a letter that J&J's McNeil Consumer Healthcare unit sent to doctors and poison-control officials that was reviewed by The Wall Street Journal.

· The company said the suspect medicines hadn't reached the marketplace, and its testing of other batches that had been released to the market didn't find any problems. "But we cannot confirm that all the individual bottles were within specification or that 24% would have been the maximum," according to the letter, which didn't indicate when or how the testing was done.

· The letter was dated May 1, the day after J&J recalled certain children's and infant's Benadryl, Motrin, Tylenol and Zyrtec cold and pain medicines after discovering unspecified manufacturing problems. The company said at the time that the medicines could contain higher concentrations of medicine than they should, among other potential issues, but didn't specify an amount.

· The J&J unit inadvertently neglected to include one version of Children's Zyrtec in the recall for five days, according to an email sent to the company's over-the-counter sales force. It told its sales force on May 5 that the 1 milligram grape version of children's Zyrtec "was inadvertently not included" in the recall.

· A spokeswoman for J&J's McNeil unit said the company sent the letter about infant Tylenol to health-care professionals in connection with the recall, and its "health assessment" indicates the chance that the recalled medicines will cause harm is remote.

· In conjunction with the April 30 recall, J&J's McNeil unit shut down the Fort Washington, Penn., plant that made the recalled products until it could fix the manufacturing issues and assure quality production. The company said that in addition to overly high concentrations of ingredients, the recalled liquid products may contain inappropriate levels of inactive ingredients or tiny metallic particles left as a residue from the manufacturing process.

· A Food and Drug Administration inspection of the plant had also found bacteria in raw materials set aside for use to make several lots of Tylenol.

Secure Pharma Chain Blog, recommends that all members of the supply chain protect their inventories and their brand by deploying authentication and material verification that will interdict issues with adulteration, fraud, counterfeit and improper manufacturing that threaten the efficacy of pharmaceuticals and the health of consumers downstream.

In the past several years, manufacturing and quality assurance concerns by pharmaceutical companies have been discovered within the supply chain that could and should have been detected at various points of the supply chain by readily available material authentication solutions.

To read the entire Wall Street Journal article, visit: http://online.wsj.com/article/SB10001424052748704912004575252923733201114.html

To learn more about supply chain security and verification solutions, visit: http://www.xstreamsystems.net/.

CNNMoney.com: Serious Side Effects of Tylenol Recall Investigated

CNNMoney.com Senior Writer Parija Kavilanz reported on May 25th on the Food and Drug Administration investigation into reports of at least 775 serious side effects from drugs recalled by McNeil, a division of Johnson & Johnson.

McNeil is also under a Congressional investigation regarding the recall, the House Committee on Oversight and Government Reform has scheduled a hearing on May 27th to examine the recall.

Highlights from the report include:

• Included in the reports were 30 deaths, nearly all of which were found to not be tied to McNeil's recall of Tylenol, Motrin and Benadryl drugs from Jan. 1, 2008 through April 30, 2010, according to another source close to the investigation.

• The FDA is also investigating reports of several hundred serious side effects -- or "adverse events" -- and seven deaths since May 1, when McNeil recalled 50 children's versions of these non-prescription medicines because of serious quality and safety concerns.

• Following the most recent recall, Johnson & Johnson (JNJ, Fortune 500) has suspended production at McNeil's facility in Fort Washington, Penn., that manufactured the children's drugs.

• The FDA, which earlier this month issued a scathing 17-page inspection report listing 20 violations at the Fort Washington plant, also maintains that the recalled drugs pose a "remote" potential for serious health problems.

• McNeil has maintained that its recall of the children's drugs was not "undertaken on the basis of adverse medical events" but as a precautionary measure.

McNeil's latest recall is its fourth in the past seven months:

• In November 2009, five lots of Tylenol Arthritis Pain 100 count with the EZ-open cap were recalled for unusual odor leading to nausea, stomach pain, vomiting and diarrhea.
• In December, the recall was expanded to include all product lots of Tylenol Arthritis Pain caplet 100 count bottles with the red EZ-open cap.
• In January 2010, the recall was widened to an undisclosed number of Tylenol, Motrin and other over-the-counter drugs after complaints of consumers feeling sick from an odor.

Secure Pharma Chain Blog, recommends that all members of the supply chain protect their inventories and their brand by deploying authentication and material verification that will interdict issues with adulteration, fraud, counterfeit and improper manufacturing that threaten the efficacy of pharmaceuticals and the health of consumers downstream.

In the past several years, manufacturing and quality assurance concerns by pharmaceutical companies have been discovered within the supply chain that could and should have been detected at various points of the supply chain by readily available material authentication solutions.

To learn more about supply chain material authentication solutions, visit: http://www.xstreamsystems.net/.

To view the CNNMoney.com story, visit: http://money.cnn.com/2010/05/25/news/companies/tylenol_recall_adverse_consumer_complaints/index.htm.

McNeil Announces Sweeping Recall of Infants’ and Children's OTC Products

In an April 30th announcement, McNeil Consumer Healthcare in consultation with the U.S. Food and Drug Administration (FDA), stated that they are voluntarily recalling all lots that have not yet expired of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured in the United States and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait.

McNeil Consumer Healthcare stated that they were initiating this voluntary recall because some of these products may not meet required quality standards.

According to McNeil the recall is not being undertaken on the basis of adverse medical events but as a precautionary measure and advises parents and caregivers should not administer these products to their children.

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, the company advises consumers who have purchased these recalled products to discontinue use.

The company 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.

Secure Pharma Chain Blog, recommends that all members of the supply chain protect their inventories and their brand by deploying authentication and material verification that will interdict issues with adulteration, fraud, counterfeit and improper manufacturing that threaten the efficacy of pharmaceuticals and the health of consumers downstream.

In the past several years, manufacturing and quality assurance concerns by pharmaceutical companies have been discovered within the supply chain that could and should have been detected at various points of the supply chain by readily available material authentication solutions.

For a complete list of the products, visit: http://www.mcneilproductrecall.com/page.jhtml?id=/include/new_recall.inc.

To learn more about supply chain material authentication solutions, visit: http://www.xstreamsystems.net/.

New York Times: In Recall, a Role Model Stumbles

Natasha Singer writes an excellent article in the January 17th issue of the New York Times regarding the recent management of a sweeping product recall by McNeil Consumer Healthcare, a division of Johnson & Johnson.

In this article, Ms. Singer explores how a company with the reputation of Johnson & Johnson, who is seen as the “gold standard” of crisis management, seemingly botches this most recent issue of product contamination within the supply chain.

Secure Chain Pharma Chain Blog has reported extensively on this particular recall and believes that this incident, which is based on onsite product contamination, energizes the need for material screening of products within the supply chain to protect consumers from fraud, adulteration, contamination and counterfeit products.

The following is an excerpt of the Ms. Singer’s article:

The Harvard Business School teaches future executives the gold standard in brand crisis management. The model dictates that a company should communicate clearly with the public about a crisis, cooperate with government officials, swiftly begin its own investigation of a problem and, if necessary, quickly institute a product recall.

The template is based on Johnson & Johnson’s conduct in 1982, when several people died after taking tainted Tylenol pills. The company’s reaction to the crisis is widely regarded as exemplary.

But last week, Johnson & Johnson appeared to abandon its own template, stunning a few business school professors. Its conduct also drew harsh criticism from federal officials.
On Friday, McNeil Consumer Healthcare, a division of Johnson & Johnson, announced the recall of several hundred batches of popular over-the-counter medicines, including Benadryl, Motrin, Rolaids, Simply Sleep, St. Joseph Aspirin and Tylenol.

According to a federal inspection report, the response was anything but swift. The recall came 20 months after McNeil first began receiving consumer complaints about moldy-smelling bottles of Tylenol Arthritis Relief caplets, according to a warning letter sent by the Food and Drug Administration to the company on Friday. Since then, a few people have also reported temporary digestive problems like nausea, vomiting and stomach pain, the agency said.

To read the entire article, visit:

http://www.nytimes.com/2010/01/18/business/18drug.html?th&emc=th

To learn more about technologies which will protect inventories within the supply chain, visit:

http://www.xstreamsystems.net/.

Johnson & Johnson: Massive Expansion of Recall

As an update to an earlier Secure Pharma Chain Blog report, Johnson & Johnson has massively expanded a recall of their OTC medications. This is the second expansion of a recall due to a moldy smell of these particular products that are making consumers ill.

The recall now includes specific lots of Tylenol caplets, gel tabs, arthritis treatments, rapid release and extend release Tylenol as well as Motrin IB, regular and extra strength Rolaids antacids, Benadryl allergy tablets, St. Joseph aspirin and Simply Sleep caplets.

McNeil Consumer Products, a division of Johnson & Johnson, is publicly stating that the expanded recall includes product lots that could be affected by the same problems of consumers experiencing nausea and vomiting that were the reason for the original recall, even though it has not received any reports from consumers.

The latest update recall applies to Johnson & Johnson/McNeil products sold in the North America, Central and South America, the UAE and Fiji.

A full list of the recalled products is online at http://www.mcneilproductrecall.com/.

Previously Johnson & Johnson recalled some Tylenol Arthritis Caplets in November and December due to the moldy smell, which caused nausea, stomach pain, vomiting and diarrhea to some consumers.

Johnson & Johnson says the smell is caused by small amounts of a chemical associated with the treatment of wooden pallets.

This recall, based on onsite product contamination, energizes the need for material screening of products within the supply chain to protect consumers from fraud, adulteration, contamination and counterfeit products.

To learn more about onsite pharmaceutical material screening solutions, visit: www.xstreamsystems.net.