Tylenol (brand)

On September 29, 1982, a "Tylenol scare" began when the first of seven individuals died in the Chicago metropolitan area after ingesting Extra Strength Tylenol that had been deliberately contaminated with cyanide. Within a week, the company pulled 31 million bottles of tablets back from retailers, making it one of the first major product recalls in American history.[8]

As a result of the crisis, all Tylenol capsules were discontinued, as were capsules of other brand names. Retained by McNeil's president, new product consultant Martin Calle of management strategist Calle & Company conceived the world's first tamper-resistant gelatin-enrobed capsule called "Tylenol Gelcaps",[7] which proved to resuscitate the 92% of capsule-segment sales lost to the recall. The tamper-resistant, triple-sealed safety containers were placed on the shelves of retailers ten weeks after the withdrawal, and other manufacturers followed suit. The crisis cost the company more than US$100 million, but Tylenol regained 100% of the market share it had before the crisis. The Tylenol murderer was never found, and a US$100,000 reward offered by Johnson & Johnson remained unclaimed as of 2013.[9]

Before the poisonings, Tylenol brands held around 35% of the US market for acetaminophen and in the immediate aftermath, fell to 8%. Within a year sales had rebounded to the prior levels.[10] J&J's handling of the crisis has been widely cited as an example of optimal crisis management.[11]

These events led to the widespread use of tamper resistance packaging of drugs by drug companies, to the 1982 passage of a US federal law making tampering a crime, and to legislation in 1989 requiring tamper-proof packaging.[10]

On January 15, 2010, a voluntary recall of several hundred batches of popular medicines was announced, including Benadryl, Motrin, Rolaids, Simply Sleep, St. Joseph Aspirin, and Tylenol.[12] The recall was due to complaints of a musty smell suspected to be due to contamination of the packaging with the chemical 2,4,6-tribromoanisole.[13] The full health effects of 2,4,6-tribromoanisole are not known but no serious events have been documented in medical literature.[14] The recall came 20 months after McNeil first began receiving and investigating consumer complaints about moldy-smelling bottles of Tylenol Arthritis Relief caplets, according to the U.S. Food and Drug Administration (FDA). The recall included 53 million bottles of over-the-counter products, involving lots in the Americas, the United Arab Emirates, and Fiji.[15]

On April 30, 2010, another recall was issued for 40 products including liquid infant and children's pain relievers Tylenol and Motrin, and allergy medications Zyrtec and Benadryl.[15] An FDA report said its inspectors found thick dust and grime covering certain equipment, a hole in the ceiling, and duct tape-covered pipes at the Fort Washington, Pennsylvania, facility that made 40 products recalled. New testing regulations were enacted after the recall to ensure product quality and safety.[16]

On May 5, 2010, the FDA confirmed[17] that the bacterium found at the Johnson & Johnson plant that made the recalled Children's Tylenol was Burkholderia cepacia, a bacterium often resistant to common antibiotics.[18] The bacteria were found on the outside of certain product-containing drums, but not in the finished product. The CDC has stated that Burkholderia cepacia is not likely to cause health problems for those with healthy immune systems, but those with weaker ones and those with chronic lung diseases, such as cystic fibrosis, could be more susceptible to infection.