Federal Antitampering Act

  

From Rx-wiki

In the early morning of Wednesday, September 29, 1982, 12-year-old Mary Kellerman of Elk Grove Village died after taking a capsule of Extra Strength Tylenol. Adam Janus of Arlington Heights died in the hospital shortly thereafter. His brother, Stanley (of Lisle), and his wife Theresa died after gathering to mourn, taking pills from the same bottle. By October 1, 1982, the poisoning had also taken the lives of Paula Prince of Chicago, Mary Reiner of Winfield, and Mary McFarland of Elmhurst. Investigators soon discovered the Tylenol link. Urgent warnings were broadcast, and police drove through Chicago neighborhoods issuing warnings over loudspeakers.

As the tampered bottles came from different factories, and the seven deaths had all occurred in the Chicago area, the possibility of sabotage during production was ruled out. Instead, the culprit was believed to have entered various supermarkets and drug stores over a period of weeks, pilfered packages of Tylenol from the shelves, adulterated their contents with solid cyanide compound at another location, and then replaced the bottles. In addition to the five bottles which led to the victims deaths, three other tampered bottles were discovered.

Johnson & Johnson, the parent company of McNeil, distributed warnings to hospitals and distributors and halted Tylenol production and advertising. On October 5, 1982, it issued a nationwide recall of Tylenol products; an estimated 31 million bottles were in circulation, with a retail value of over $100 million. The company also advertised in the national media for individuals not to consume any products that contained Tylenol. When it was determined that only capsules were tampered with, they offered to exchange all Tylenol capsules already purchased by the public with solid tablets.

The perpetrator has never been caught, but the incident led to reforms in the packaging of over-the-counter substances and to federal anti-tampering laws.

See also

Federal pharmacy law

References

  1. Food and Drug Administration, Legislation, http://www.fda.gov/RegulatoryInformation/Legislation/default.htm
  2. Food and Drug Administration, History, http://www.fda.gov/AboutFDA/WhatWeDo/History/default.htm
  3. CNN, Seven dead in Tylenol tampering scare -- October 1982, http://www.cnn.com/resources/video.almanac/1982/index2.html#tylenol