Tylenol product tampering

In 1982, seven people died from consuming cyanide-laced Tylenol capsules. The incident resulted in a total product recall, massive negative pubHcity for the product, new requirements for safe packaging, and a federal statute making product tampering a crime (2). Since that time, the packaging industry has become visible to most consumers. This awareness has benefited the consumer by a reduction in loss of life due to consumption of adulterated products from tampering. Never before has an industry reacted so swiftly to resolve a problem. 

Copycats afterwards, 36 product tampering episodes. Tylenol was reintroduced with new tripleseal tamper-resistant packaging six weeks later. J J offers coupons, discounts, J J affiliates make presentations to medical community Tylenol comeback was a success. 

Tylenol products were tampered with when cyanide was placed inside Tylenol capsules. The regulation required visible product tampering methods that would alert the cousumer to the fact that the product may have been tampered with. This regulation made it a crime for an individual to tamper or threateu to tamper with consumer products. 

Deliberate contamination of Tylenol capsules in 1982 with cyanide prompted the Federal Antitampering Act (P.L. 98-127) (18 U.S.C. 1365). This act applies to all consumer products, including any food, drug, device, or cosmetic. If a product is not packaged according to the Food, Drug, and Cosmetic Act, the product is considered misbranded or adulterated. For the purpose of consumer products, tampering refers to any alteration of the product with the intent to make the product ohjectionahle without the authority to make the alteration. 

Police drove through Chicago warning people with loudspeakers. FDA advised avoidance of Tylenol capsules. J J immediately recalled 31 million bottles and alerted consumers not to consume capsules until source of tampering was determined. The production and advertising of Tylenol capsules were stopped, and tablets were exchanged for capsules. 

Tamper-resistant packaging required after the deaths from cyanide placed in Tylenol, and the Federal Anti-Tampering Act makes it a crime to tamper with packaged consumer products. 

Tamper-evident and tamper-resistant packs were few and far between until the Tylenol incident in the USA, when such packaging became the rule for OTC products almost overnight. WHO, in its guideline on the assessment of medicinal products for use in self-medication, recommends that such packages are highly desirable. 

The earlier use of the word tamper-proof has been replaced by tamper-evidence and tamper-resistance. The Extra Strength Tylenol incidences between 29 September and 7 October 1982 in the USA, whereby seven people were killed by cyanide and the copycat poisonings which followed, provided a worldwide alertness to the issue. Although TE/TR cannot offer total security it does offer some assurance that the product has not been contaminated, some of the contents removed and possibly... 

In 1982, a very popular, over-the-counter painkiller, Tylenol, became the vehicle for murder. Someone replaced capsules with cyanide-laced capsules that looked like the originals. The criminal, who was never caught, returned tampered containers to store shelves. Seven buyers died when they purchased and consumed tampered pUls. The events led to a 100 million product recall and intermpted market share for a long time. 

The Tylenol tampering incident in the 1970s had a profound effect on Johnson Johnson, as well as every other manufacturer of consumer medical products, and on how these products were sealed and packaged. 

Thus the company must choose whether it wishes to invest in designing the product to minimize the probability of recall or incur the cost of a possible recall. Johnson and Johnson, following a recall in 1982, redesigned Tylenol as caplets instead of capsrdes (Catalin Group 2012). The caplets were tamper proof, whereas, the capsules laced with cyanide triggered the recall. 

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