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?

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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.

ABC News: FDA Looking into Tylenol Arthritis Pain Caplets Recall

ABC World News is reporting that the US Food and Drug Administration is investigating the process of the recall and the way that it has been communicated to consumers.

November, Tylenol posted a small recall on its website. Twelve days ago, all six million bottles were recalled. However, it wasn't until a nationwide FDA medical alert just this Monday that most people learned the bottles had been recalled.

In an analysis piece aired on ABC World News, ABC’s Senior Medical Editor Richard Besser, MD, advised consumers what actions to take if they have the recalled Tylenol. Dr. Besser explained that consumers who have the Tylenol arthritis caplets in the Easy Cap bottles should get rid of them by safely disposing them in their trash.

On Wednesday, the deputy commissioner of the FDA, Joshua M. Sharfstein, MD, said the agency is "looking into...the case," additional stating "a system that relies on the consumer to either visit websites or to sign up for multiple web blogs or email alerts, I don't think is the way we want to alert consumers about recalls."

Tylenol Pain Caplets Recalled Due to Trace Chemical Which Causes Nausea and Vomiting

The Associated Press and other major media outlets are reporting that Johnson & Johnson is expanding a voluntary recall of Tylenol Arthritis Caplets due to consumer reports of a moldy smell that can cause nausea and sickness.

The FDA released a statement on their website that Johnson & Johnson is now recalling all product lots of the Arthritis Pain Caplet 100 count bottles with the red EZ-Open Cap. Johnson & Johnson had previously recalled five lots of the product last month after consumers complained of a musty, mildew-like odor that triggered nausea, stomach pan, vomiting and diarrhea.

Johnson & Johnson is saying that the odor results from trace amounts of a chemical called 2, 4, 6-tribromoanisole. That chemical is believed to result from the breakdown of another chemical used to treat wooden pallets that transport and store packaging materials. To date, the side effects, which also include vomiting and diarrhea, have been "temporary and non-serious," although the health effects of the compound have not been studied.

The company will reintroduce Tylenol Arthritis Pain Caplets 100 count by January after moving production to a new facility.

For more information on the recall visit the Tylenol website: http://www.tylenol.com/.

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.