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/.

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: 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.