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/

'What's in the Bottle': Launch of New Series in Pharmacy Today

Pharmacy Today, the magazine published by the American Pharmacists Association (APA) in July started a new series of articles about "What's in the Bottle".

As the publisher L. Micheal Posey in the July edition so aptly writes in his Today's Perspective:

Pharmacists and the public recently have faced a rash of extensive and disheartening recalls of medications. It's difficult to know whether something is amiss in the world of quality control or if this is just another symptom of the general problems in today's world. We do, after all, seem to be living in an era where humanity's technologic and scientific prowess seems to be exceeding the ability to predict and handle problems (think oil spill) and where some companies appear to be viewing product-liability problems as remote possibilities or perhaps another line on their balance sheet (consider some of the settlements and fines paid by pharmaceutical companies in recent years, with amounts in the hundreds of millions or even billions of dollars).

As detailed in FDA inspection reports and other documents, some companies in the ethical pharmaceutical industry are engaging in practices once thought of as completely out of the question: use of contaminated raw materials, product of medications outside current Good Manufacturing Practices, and release of products that have failed quality control tests.

At the same time, the shift of contract pharmaceutical manufacturing to other countries is taxing the U.S.-based FDA's ability to oversee manufacturing processes of companies making prescription medications, nonprescription products, and dietary supplements. Counterfeit medications are found far too often in the medication-supply chain in the United States and elsewhere. Drug products are being stolen by the truckload from warehouses and during interstate transport and diverted to the largely illegal Internet-based market or to collaborating buyers in the health profession who are eager for the "savings". Pharmacies are being robbed and burglarized for the valuable medications they stock, with diversions going mostly to the illicit market bu perhaps some back int the pharmaceutical supply chain.

These situations have pharmacist wondering. "What's in the bottle?"

The July edition of Pharmacy Today has an excellent first piece in the series titled, Empty Shelves: Med Recalls Creating Questions which details to newest challenges faced by the pharmaceutical supply chain and industry giants Baxter and McNeil.

Secure Pharma Chain is excited that publications that cater to pharmacists are begining to weigh in on the critical issue of supply chain safety and the huge business that fraudulent, adulterated, diverted and counterfeit medications have become.

Ultimately Secure Pharma Chain believes that pharmacists as with other members of the pharmaceutical supply chain must take measures to authenticate and validate their inventories before they pass them onto the consumer.

Technologies exist today that enable the supply chain to efficently and economically authenticate pharmaceuticals within their sealed unit-of-sale container.

To read the Pharmacy Today series, visit: http://www.pharmacytoday.org/.

To learn more about pharmaceutical authentication 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.

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.