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Johnson & Johnson’s McNeil Consumer Healthcare, already under Congressional investigation for selling allegedly tainted Tylenol, announced late Tuesday that it was recalling other products made in the Puerto Rico manufacturing facility in question.

According to an article in today’s New York Times, “McNeil Consumer Healthcare, the Johnson & Johnson unit, said that it was recalling four lots of certain Benadryl allergy tablets and one lot of Extra Strength Tylenol gel pills. McNeil did not respond to a reporter’s query about how many bottles those lots amounted to.”

Since last November, McNeil has recalled about 11.7 million bottles of various Motrin products and about 6.3 million bottles of Tylenol Arthritis Pain caplets made at the Puerto Rico plant in question. The company began the product recall after receiving numerous consumer complaints about a moldy odor emanating from some of its products.

Company representatives contend that the moldy smell was caused by contamination from a chemical byproduct of a substance used to treat wooden transport pallets. Further, McNeil suggested that the risk of serious medical problems was remote and people should not stop using the products (yeah right).

The current recall just adds to McNeil’s growing manufacturing problems. The company is already under scrutiny by the House Committee on Oversight and Government Reform over a recall last April of an estimated 136 million bottles of liquid pediatric Tylenol, Motrin, Benadryl and Zyrtec.

I suspect that more problems will be uncovered as the FDA and Congressional investigations continue. Serious manufacturing and quality problems can almost always be avoided or minimized when company executives and management makes a bona fide commitment to quality systems. Clearly, the heads of McNeil Consumer Healthcare might benefit from remedial current good manufacturing practices (cGMP) training.

Until next time...

Good Luck and Good Job Hunting!!!!!!!

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Johnson & Johnson is arguably one of the world leaders in bringing social media to the pharmaceutical industry. Marc Monseau and his dedicated team oversee a network of blogs, video channels and Twitter feeds while some of J&J’s brand companies even sponsor patient advocacy communities like ADHD Moms and ADHD Allies. However, the company’s recent handling of manufacturing problems and recall of Tylenol and other pediatric medicines seemingly flies in the face of openness and transparency; two of the underlying tenets and guiding principles of social media.

In an article in today’s New York Times, Natasha Singer reports that “a Congressional investigation into a recent recall of children’s Tylenol and other pediatric medicines has been stymied by the manufacturer, Johnson & Johnson, raising the prospect that new measures — like issuing of subpoenas to compel cooperation — could be invoked.”

McNeil Consumer Healthcare, the unit that manufacturers Tylenol and other over-the-counter medications, is no stranger to scrutiny by the US Food and Drug Administration (FDA). It is currently being investigated for a pattern of violations in manufacturing practice and quality control issues that have led to recalls of several medications. Last month, the agency suggested that it was considering criminal penalties or other actions against McNeil executives.

According to the times article, the House committee opened its investigation in early May shortly after McNeil announced a voluntary recall of liquid pediatric Tylenol, Motrin, Benadryl and Zyrtec. FDA investigators uncovered evidence that the products, made at a company plant in Fort Washington, Pa., may have included metal particles, or too much of the active drug ingredient, or inactive ingredients that did not meet testing standards.”

Manufacturing problems are not uncommon in the pharmaceutical industry and it isn’t clear what J&J has to lose by not fully cooperating with FDA officials. In fact, failure to cooperate could lead to harsher penalties and larger fines. However, I suspect that McNeil hasn’t been forthcoming because of allegations of a so-called “phantom recall” that took place last year, where J&J contractors secretly removed alleged defective products from store shelves.” Nevertheless, ongoing media coverage of the recall and the circumstances behind it are beginning to cast a very negative light on McNeil products and the J&J brand.

Pharmaceutical social media advocates contend that one of the reasons why pharma companies ought to use social media tools is information dissemination and so-called damage or crisis control. While I haven’t been assiduously screening all of the J&J social media channels, it seems like now would be an ideal time to begin to leverage them. 

It is unfortunate that an innovative and progressive pharmaceutical company like J&J has come under fire. However, product quality and safety is of paramount importance to consumers. And companies that cannot ensure those product attributes must move quickly and decisively to reinstate them. To that end, J&J ought to fully cooperate with FDA regulators, fix its Tylenol problems and then use its abundant social media channels to reinstate public confidence in McNeil Consumer Healthcare and the J&J brand! After all, isn’t that what social media is all about?

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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