MCNEIL
CONSUMER PRODUCTS COMPANY
CAMP HILL ROAD
FORT WASHINGTON, PA. 19034
STATIGRAM
Electronic Dispatch
OCTOBER 1. 1982
RICHARD S. HODGSON, M.D.
POST OFFICE BOX 46
WESTTOWN, PA. 19395
DEAR DR. HODGSON:
MCNEIL CONSUMER PRODUCTS COMPANY HAS CONFIRMED THAT SEVERAL BOTTLES OF ITS PRODUCT, EXTRA-STRENGTH TYLENOL CAPSULES, HAVE BEEN TAMPERED WITH AND CYANIDE POISON ADDED TO SOME OF THE CAPSULES. THESE INCIDENTS HAVE ALL OCCURRED IN THE CHICAGO AREA AND WE ARE TAKING STEPS TO REMOVE FROM SALE IN THE CHICAGO AREA ALL EXTRA-STRENGTH TELENOL CAPSULES.
THE BOTTLES IN QUESTION, WHICH CONTAIN 50 CAPSULES, WERE FROM TWO LOTS OF PRODUCT WHOSE NUMBERS ARE MC2880 AND 1910MD. PRODUCTS MARKED IN THIS WAY SHOULD NOT BE BOUGHT OR CONSUMED, AND CONSUMERS HAVING SUCH PRODUCT SHOULD RETURN IT TO THE PLACE OF PURCHASE OR TO MCNEIL CONSUMER PRODUCTS COMPANY.
ALTHOUGH WE BELIEVE THE PROBLEM IS CONFINED TO THE CHICAGO AREA, WE ARE TAKING THE PRECAUTION OF WITHDRAWING THESE TWO LOTS EVERYWHERE THEY ARE IN DISTRIBUTION. WE CURRENTLY HAVE NO EVIDENCE THAT ANY OTHER EXTRA-STRENGTH TYLENOL CAPSULE OR OTHER TYLENOL PRODUCT WAS SIMILARLY CONTAMINATED.
*REGISTERED TRADEMARK OF MCNEIL CONSUMER PRODUCTS COMPANY
McNEIL
McNEIL CONSUMER PRODUCTS COMPANY, CAMP HILL ROAD, FORT WASHINGTON, PA 19034, [215] 233-7000
October 8, 1982
11:00 A.M.
Dear Doctor:
On Thursday morning, September 30, 1982, the Cook County, Illinois, Medical Examiner’s Office advised McNeil Consumer Products Company that three deaths due to cyanide poisoning had occurred in the northwestern suburbs of Chicago. At that time, a fourth victim was critically ill and has subsequently died. Extra-Strength TYLENOL Capsules. Three of the deaths were in one family and involved a single 50-capsule bottle of Extra-Strength TYLENOL Capsules with the Lot #MC2880. The fourth death associated with a bottle of Extra-Strength TYLENOL Capsules with the same lot number.
McNeil Consumer Products Company immediately notified the Food and Drug Administration and initiated a national recall of all Extra-Strength TYLENOL Capsules with that lot number. In addition, all Extra-Strength TYLENOL Capsules, regardless of lot number, were recalled in the seven county area around Chicago.
Three additional deaths, all in the Chicago area, have subsequently been traced to Extra-Strength TYLENOL Capsules that had been tampered with.
Further, on Friday, October 1, a case of strychnine poisoning due to adulteration introduced through tampering with Extra-Strength TYLENOL Capsules was reported in Oroville, California, a small community approximately 100 miles north of Sacramento. As various lots of Extra-Strength TYLENOL Capsules were identified in these events, they were withdrawn either nationally or regionally as the circumstances indicated.
The situation has rapidly changed over the past six days. McNeil has therefore now established the following policy pertaining to hospital, and retail and consumers:
In agreement with the FDA, McNeil Consumer Products Company is voluntarily withdrawing all TYLENOL capsule products (including Regular Strength TYLENOL Capsules, Extra-Strength TYLENOLE® Capsules, non-blistered CoTYLENOL® Capsules, and Maximum Strength TYLENOL Sinus Medication Capsules) from hospital, wholesale and retail accounts nationally. In addition, McNeil Consumer Products Company is advising all TYLENOL capsule users to now use TYLENOL tablets until capsules in tamper-resistant packages are available. Consumers are urged to return all TYLENOL capsule to the place of purchase or to mail bottles to Tylenol Exchange, P.O. Box 2000, Maple Plains, Minnesota 55348, They will receive TYLENOL tablet products in exchange.
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We are assisting local, state and national law enforcement agencies, as well as the FDA, in every way possible to identify who tampered with the Extra-Strength TYLENOL® Capsules and have offered a $100,000 reward for information leading to the arrest and conviction of the person or persons responsible for the murders in Chicago.
We have, of course, thoroughly examined the possibility that Extra-Strength TYLENOL Capsules were tampered with at our manufacturing locations or distribution channels. We have continued to use all of our research and quality assurance capabilities --- and those of other Johnson & Johnson subsidiaries --- to make certain there is no possibility that cyanide or strychnine poison were introduced during our handling of the product. We are confident that no contamination took place in our facilities.
There is widespread public confusion about which TYLENOL products are involved. Many people do not understand that it is only Extra-Strength TYLENOL Capsules and possibly Regular Strength TYLENOL Capsules that have been implicated and that tablets could not be tampered with in the same manner as capsules.
Because of this confusion, some media have questioned Extra-Strength TYLENOL Tablets, pediatric formulations and all of our other products. There is no evidence indicating that any other products of either McNeil Consumer Products Company or McNeil Pharmaceutical, including TYLENOL® with Codeine, have been tampered with in any manner. We would sincerely appreciate your assistance in reassuring your patients that there is no evidence that the tablet and pediatric forms of our products have been tampered with. If you have any questions, please call me collect at (215) 233-7262.
McNeil Consumer Products Company appreciates the many expressions of confidence in our company and in the quality of our products we have received from every segment of the health care profession. Our company is proud of our ethical image and we will do everything in our power to continue to justify our trust and confidence.
Sincerely,
Thomas N. Gates, M.D.
Medical Director
McNeil Consumer Products Company
