The Tylenol Crisis

The Tylenol crisis occurred in October of 1982 when seven people died in Chicago after immediately taking extra-strength Tylenol capsules. Tylenol was the leading non-prescription pain reliever medicine at that time. The capsules were popular in particular because they were slicker and easier to swallow. It was later found out that the capsules that were taken by these people were laced with a very lethal dose of cyanide. The Tylenol brand name is owned by McNeil Consumer Healthcare which is a subsidiary of Johnson & Johnson. The company Johnson & Johnson established that the cyanide lacing happened after the Tylenol cases already left the factory. Food and Drug Administration officials hypothesized that the culprit took Extra-Strength Tylenol

They worked with FDA officials to create new tamper-evident packaging including foil seals and other obvious features that could warn consumers of foul play. The company also promoted caplets (tablet coated with easy to swallow gelatin) which are more difficult to tamper with. They also lowered the price of Tylenol by 25% to recover lost stock from the crisis. Sales people made presentations about the new product to the medical community to ensure confidence in the product. Within about a year, the company was able to get sales back to normal and Tylenol became the leading over-the-counter pain reliever once again. A “Tylenol bill” was passed by the U.S. Congress based on this incident which made it a federal offense to tamper with consumer

Some of these guidelines can be found in the Code of Federal Regulations under Title 21, part 211, subpart E and I. For example, now all components and drug product containers need to be closed to prevent contamination. Containers should also be identified with a distinctive code for each lot so the status of those lots can be identified: approved, rejected, or quarantined. The quality control unit also needs to sample, test, and examine all lots before they can be released for use. This is to ensure that each lot is safe and has been thoroughly tested. Any components that have been rejected should be dealt with under a quarantine system which keeps them from being used in manufacturing. All equipment and containers need to be properly sterilized to protect from any sources of contamination because they could cause serious risks if not dealt with appropriately. Many laboratory controls are set into place to properly test batches of drug products for stability. Since incorrect dosage in drugs can easily be lethal, it’s crucial that these regulations test products especially for expiration dates and appropriate storage