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: Hold Your Nose, Pfizer Recalls More Smelly Lipitor

For the second time in three months, Pfizer is recalling thousands of bottles of its Lipitor cholesterol pill after smelling a musty odor.

Ed Silverman in Pharmalot is blogging on another Pfizer Lipitor recall due to the product containing a musty, unpleasant odor.

According to Mr. Silverman:

• The drugmaker already recalled 191,000 bottles of Lipitor - but only the 40mg dose - after receiving consumer reports last July. Once again, the problem is blamed on packaging supplied by another company.

• “The company has identified the source of the problem - the bottle manufacturer’s plant in Puerto Rico, which had shipped empty bottles to the Pfizer plant in Freiburg, Germany for use in packaging Pfizer products,” according to a Pfizer statement.

• The drugmaker adds that the risk of health consequences to patients “appears to be minimal, and steps are being taken to preserve product quality and patient trust,” although still more recalls may occur.

• Musty odors are a growing problem for Pharma. The recall scandal enveloping J&J’s McNeil Consumer Healthcare unit came to light after the FDA earlier this year released a warning letter that the health care giant failed to take sufficient action in response to batches of Tylenol Arthritis Relief Caplets that had a musty smell.

• This is getting costly for Pfizer. Assuming these are the same 90-count bottles that were recalled last time and that these sell for at least $1.50 each, or roughly $135 a bottle, that amounts to $5.13 million at retail, since the pricing comes from PharmacyChecker.com.

• Add that to the $25.7 million from the last recall and the total retail value is now north of $30 million.

Pharmaceutical companies need to protect their brand and the consumer by deploying quality assurance testing of their product, post-production within the supply chain.

Not considered in Mr. Silverman's cost calculations are the cost of managing and returning the recalled product which easily doubles the actual retail cost of the product.

Once mighty brands are losing consumer confidence due to quality control problems that could and should be easily resolved.

Like the issue with J&J this contamination occurred because of issues with a chemical used in the pallets used to store and ship the product. Many things can impact the quality and efficacy of the drug within the supply chain.

To read the entire Pharmalot post, visit: http://www.pharmalot.com/

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

Pharmalot: Moms and Docs Think Less of Johnson & Johnson

A new survey finds the health care giant’s reputation has declined 27 percent among mothers, 31 percent among pediatricians and 23 percent among general practitioners.

Once again, Ed Silverman in the September 29th edition of his Pharmalot blog, examines the repercussions to the reputation of industry giant J&J in the wake of their recent recall scandal.

Here are some of the highlights of the blog post:

• If anyone thought the very messy recall scandal would blow over and Johnson & Johnson would emerge unscathed, they may want to think again. A new survey finds the health care giant’s reputation has declined 27 percent among mothers, 31 percent among pediatricians and 23 percent among general practitioners.

• Looked at another way, all three groups rated its reputation as an 8 - on a scale of 1 to 10 with 1 as horrible and 10 as perfect - before the recalls. Now, all three groups rate J&J between 5 and 6. The survey of 139 mothers and 50 physicians was conducted by CLSA analyst David Maris, who says that, since some moms will moms and docs have permanently changed their view of J&J, “this is serious.”

• On a scale of 1 to 10, with 1 = not serious at all and 10 = extremely serious, moms were asked how serious they believed the recalls were. The average rating was 7.3. Meanwhile, 72 percent of the moms said the recalls have not permanently changed their view of J&J, and 56 percent will continue to trust the J&J brand. But 28 percent say the recalls have permanently changed their opinion. Of pediatricians, 60 percent will not change their prescribing habits for J&J products, but 28 percent of pediatricians and 36 percent of GP's say the recall is a serious quality issue.

• 53 percent of the moms trust J&J the most when compared to store-brand products offered by Wal-Mart and CVS, but 29 percent thought J&J brands were no better or worse than those store brands. And 48 percent of the docs say they may prescribe or recommend more non-J&J products in the future given the recall. Such as? generic versions of ibuprofen, acetaminophen,
diphenhydramine, Merck/SGP’s OTC Claritin, and Pfizer’s Children’s Advil. A field day for J&J rivals, yes?

• The health care giant is under a microscope for allegedly trying to hide from the FDA and consumers that some products were tainted and the hearing will be the first time that Weldon has appeared in public this year to address the problem. Small wonder moms and docs react the way do.

• Here’s how one doc answered the survey: “Your products are still not available. You have made my job more difficult. Answering tons of calls regarding the lack of fever reducer for children - “what do we do now?” Use generics, they are just as good.” And another: “Not permanently damaged, but J&J will have to do major PR to earn back customer’s trust and confidence in their products. Have to remember target audience like moms who are scared to death to use J&J products on their beloved children.”

• “We think negative changes in corporate reputations are serious and the ramifications may be slow to become apparent,” he writes in a report. “Doctors and consumers think that there are more things J&J can do to rebuild trust and confidence, with open and direct communication being most highly cited. Time will tell whether J&J successfully rebuilds this confidence and whether there are any longer-term consequences for the recalls.”

Clearly the entire pharmaceutical supply chain needs to take lessons from J&J’s mis-steps. Quality control and protection from fraudulent, adulterated and counterfeit medications are taking a serious toll on all of the members of the supply chain, not to mention most importantly the consumer.

To read the Pharmalot blog, visit: http://www.pharmalot.com/2010/09/moms-and-docs-think-less-of-johnson-johnson/#more-26662.

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

Pharmalot: Killing Snakes with Bad Tylenol

Pharmalot has a great suggestion for the J&J CEO to turn the recent recalls into a win-win.

Ed Silverman in his September 8th blog titled, Snake in the Grass, J&J Can Recoup Tylenol Losses, has come up with a novel way to turn this bad situation by donating the recalled Tylenol to the U.S. military for “a perfectly good cause”.

Apparently the U.S. military has come up with a solution for their invasive brown tree snake problem at their naval base in Guam. They have discovered that snakes die when they consume acetaminophen. They now are proposing dropping mice fed with acetaminophen from a helicopter into the jungles surrounding the base…

As Mr. Silverman so eloquently elaborates:

Snakes, after all, do not care if their Tylenol smells musty or contains metallic flecks. Grind ‘em up, feed ‘em to the mice, drop the mice in the jungle and, voila, no snakes. And for Weldon, no embarrassing trips to the landfill.

“The discovery that snakes will die when they eat acetaminophen was a huge step forward,” Anne Brooke, conservation resources program manager for Naval Facilities Command Marianas, tells Stars and Stripes “The problem was how you get the snakes to eat it.”

Putting Guam aside for a moment, this could be the public relations coup that Weldon so desperately needs. Rather than sheepishly dispose of millions of Tylenol tabs in the middle of the night, he and his new quality control team can be photographed proudly donating the poorly made goods to an effort that serves vital US interests. And best of all - J&J may be able to realize a tax break in the process. How’s that for leadership possibilities?

I guess if you are the CEO of J&J you have to take the lampooning when under your watch, your company so thoroughly botches quality control and the subsequent attempt to cover its tracks from the consumer and the government.

Clearly the entire situation is a cautionary tale for the entire supply chain. Thankfully for all, the only fatalities to this recall, other than some careers and stock portfolios, will be to the population of the brown tree snake in Guam.

To read the Pharmalot post, visit: http://www.pharmalot.com/2010/09/snake-in-the-grass-jj-can-recoup-tylenol-losses/

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

Johnson & Johnson Announces Plan To Revamp Its Quality Controls

On the heels of the massive recalls due to quality control issues with some of it most popular and profitable lines, J&J is announcing its plans to appoint Chief Quality Officers for each of its three major divisions.

J&J company spokesman Bill Price stated, "the chief quality officers and the creation of a new position are part of a 'more comprehensive remediation plan' for the company."

Given the state of the pharmaceutical supply chain, as globalization proliferates and even industry giants find themselves suffering from poor quality, raw material adulteration, fraudulent products and counterfeits, it seems logical that all members of the supply chain integrate technologies to authenticate and verify the product within its individual inventories is genuine, safe and clinically efficacious.

Stakeholders in the supply chain have too much at stake to rely solely on inventory control measures, pedigrees, bar codes and serialized numbers, they must take measures to insure the safety of the products that they sell. It is important to know where the box has been but it is vital to know what is in the box.


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

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/.

Pharmalot: How Can J&J Recover From The Recall Scandal?

Once again Ed Silverman in his leading pharmaceutical insider blog Pharmalot continues to scoop the media with some of the most insightful perspectives on the recent Johnson & Johnson Recall Scandal.

In his latest Pharmalot blog piece, he interviews Laura Ries a Marketing Consultant for her take on how Johnson & Johnson handles their image in the midst of this continuing saga.

To view this excellent Pharmalot blog, visit:
http://www.pharmalot.com/2010/06/how-can-jj-recover-from-the-recall-scandal/#more-23772.

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/.

Phamalot: Johnson & Johnson And Its Mystery Shoppers

Pharmalot, Ed Silverman’s excellent pharmaceutical insider blog posted a riveting blog on the continued saga of the truth behind Johnson & Johnson's recent recalls of its hugely popular over-the-counter brands which included Motrin and Tylenol.

Currently the industry giant finds itself in embroiled in Congressional investigations and regulatory review from the FDA which may involve criminal charges.

Here are some of the highlights from the Pharmalot blog:

· The Johnson & Johnson recall scandal is threatening to envelope the healthcare giant in ways that, just a few months ago, no one could imagine. The latest twist involves a series of emails that appear to lend further credence to what a Congressional committee is calling a ‘phantom recall,’ which was allegedly undertaken to obscure serious problems with widely used over-the-counter pediatric medications. The episode is part of a long-running chain of events may prompt the FDA to consider criminal charges.

· At issue are quality-control failures that forced J&J to recently recall tens of millions of bottles of such venerable brands as Tylenol and Motrin, among others, which had been found to contain too much active ingredient or metallic specks. But instead of issuing a recall, J&J hired an outside contractor to buy Motrin from stores, and its employees were instructed to act like “regular customers” and not discuss a possible recall. This was disclosed at a May 27 Congressional hearing.

· Since then, internal J&J documents obtained by Pharmalot would appear to undercut some of J&J’s contentions, such as the notion that its contractor’s assignment was limited and transparent. A J&J spokeswoman told The New York Times the contractor’s memo was created without the knowledge of its McNeil Consumer Healthcare unit. But e-mails suggest J&J employees were aware, including Lily Vandermolen, an associate product director at McNeil, and Carolyn Parziale, a diretor of quality assurance at McNeil.

Mr. Silverman’s blog goes into detail about Johnson & Johnson’s insider knowledge and it would surely mean that there are many documents that leave a trail to an institutional knowledge of the product out in the supply chain was well known to have quality issues and be potentially harmful to the consumer.

Secure Pharma Chain Blog endorses that all members of the pharmaceutical supply chain deploy technologies and solutions to actively verify the authenticity and quality of its inventories to protect themselves and the consumers from poor quality control, adulteration, fraud and counterfeit product.

To learn more about authentication technologies that can verify pharmaceutical products inside their sealed unit-of-sale container, visit: http://www.xstreamsystems.net/.

To read the entire Pharmalot blog, visit: http://www.pharmalot.com/2010/06/johnson-johnson-and-its-mystery-shoppers/#more-23843.

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.

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.

WSJ: US Authorities Investigating Alleged Sales Of Counterfeit Insulin Test Strips

Peter Loftus in the Wall Street Journal reports that the US government is currently investigating a Florida businessman who Johnson & Johnson says sold counterfeit versions of its OneTouch diabetes test strips.

J & J has aggressively conducted this investigation, which it says involves participants in China, Pakistan and the US, for the last four years.

According to the WSJ, if charges are filed against the US distributor, Jacques Duplessis, it would be the first instance resulting from J&J's four-year effort. Notably, a 2006 FDA alert about the counterfeit strips warned that they could give inaccurate readings, causing diabetes patients to take either too much, or too little, insulin.

This incident is very relevant in that it shows that the prevalence of counterfeit medications and devices that have been a major issue in the rest of the world outside of the United States has been impacting our consumers and will likely proliferate further.

Secure Pharma Chain Blog encourages all members of the pharmaceutical supply chain to use a variety of technology solutions to secure their inventories specifically material authentication which allows the user to verify the molecular fingerprint of the tested material inside its unit-of-sale container.

To learn more about anti-counterfeiting solutions, visit: http://www.xstreamsystems.net/.

To read the WSJ article, visit: http://online.wsj.com/article/SB10001424052702303591204575169990446786552.html.

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.