Manufacturer Recalls Sudafed Capsules After Link to Deaths, Illness
SEATTLE (AP) _ The makers of Sudafed 12 Hour capsules pulled the popular cold medication off store shelves across the nation as federal authorities investigated two deaths and an injury involving cyanide-laced capsules.
Burroughs Wellcome Co. ordered the recall of about 1 million packages on Sunday, advising customers to return the product to the store where they bought it. The day before, state and federal officials revealed they were investigating the poisonings, which took place in the Tacoma and Olympia areas.
Authorities said, they are still trying to determine if the victims had anything in common other than their separate purchases of the tainted over- the-counter cold remedy. Investigators gave no possible motive for the tampering.
Meanwhile, a capsule that showed signs of tampering was returned to a Tacoma-area store after the recall order was issued Sunday, authorities said. Tests were being conducted to determine whether it contained cyanide.
FBI agent Dick Thurston said the four Sudafed packages came from different stores.
″Despite what appears to be a localized situation, the company has decided to institute a nationwide recall,″ said Phil Tracy, president and chief executive officer for Burroughs Wellcome, based in Research Triangle Park, N.C.
About two dozen federal Food and Drug Administration agents combed stores in the three counties Sunday to ensure the medication was removed from shelves.
Local police and federal authorities launched an investigation Feb. 15 after learning that Jennifer Meling, 28, of Tumwater, an Olympia suburb, had become seriously ill after taking Sudafed laced with cyanide two weeks before.
Then, on Friday, authorities learned that Kathleen Daneker, 40, of Tacoma had Sudafed and cyanide in her body when she died Feb. 11.
On Sunday, authorities learned that Stanley McWhorter, 44, of Lacey died Feb. 18 of cyanide poisoning after taking Sudafed capsules.
McWhorter was cremated and his vital organs given to the Northwest Organ Procurement Agency before it was learned he had been poisoned. But authorities said blood and tissue samples were taken from his body before the cremation.
Laurie Peterson, a supervisor with the organ procurement agency, said the organ recipients apparently suffered no problems.
″It would have probably been reported to us already had there been serious problems,″ she said. ″I’m pretty certain that things are all right.″
Susan Hutchcroft of the FDA declined to say how the cyanide was believed to have introduced into the capsules. Sudafed has tamper-resistant packaging and capsule design because of earlier scares.
Company officials said they believe any tampering occurred after the products left the Greenville, N.C., plant where they were packaged.
All three victims consumed Sudafed from blister packs bearing the lot number 8U2846. The boxes bore the lot numbers 002847 and 8U2849.
Officials speculated that the tainted Sudafed capsules probably were taken from one box, laced with cyanide and sealed in another box.
″When they are packaged at our plant, they (the lot numbers) match,″ Tracy said.
Sudafed packaging has three tamper-resistant features: a blue gelatin band around the capsule that makes it impossible to take apart; the aluminum and plastic blister pack; and the carton, which has tape on either end that will break if someone tries to open the package.
David Barry, Burroughs Wellcome vice president of research and development, said that nothing is tamper-proof.
″If you really try hard, you can always tamper with this product - or any product,″ he said.
Sudafed 12 Hour accounted for $15 million in sales last year, company officials said.
Meling, a Tumwater teacher, still suffers dizziness and heart palpitations from the Feb. 2 poisoning, said her husband, Joseph Meling.
″She called me from the bedroom and I called 911 and luckily everything happened fast enough that she survived,″ he said. ″It was nothing short of miraculous. ... You don’t survive cyanide every day.″
In 1986 two people in south King County, Wash., died in a cyanide tampering case involving Extra-Strength Excedrin. Stella Nickell, convicted of killing her husband and another person, is serving 270 years in prison.
In 1982 seven people died of cyanide-tainted Tylenol capsules in Chicago, and almost five years ago a cyanide-laced Tylenol capsule killed a New York woman. Those killings have never been solved.
In 1986, Edward Arlen Marks pleaded guilty to putting rat poison into Contac, Teldrin and Dietac capsules in Houston and Orlando.
Authorities said Marks bought options on stock issued by SmithKline Beckman Corp., the maker of the drugs, and hoped to make a fortune by creating a panic that would drive down the price of the company’s stock.