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/

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/

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/.

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: 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.