A week after Utah retailers removed Sudafed 12-Hour capsules from their shelves, a ShopKo-brand pain reliever also has been yanked.
Jane Kresin, spokeswoman for ShopKo Stores, based in Green Bay, Wis., said Tuesday the 500-milligram, non-aspirin (acetaminophen) caplets will remain off shelves in several states until federal tests determine whether a damaged bottle purchased in Minnesota had been tampered with.Besides Minnesota and Utah, ShopKo stores participating in the recall are in Wisconsin, Nebraska, Idaho, South Dakota, Washington, Iowa, Michigan, Nevada, Oregon, Montana and California.
Kresin said the medication was removed after a Mankato, Minn., detective was notified Saturday by a Le Sueur County resident who found that the bottle cap on the ShopKo brand extra-strength, non-aspirin caplets was screwed on improperly. The foil seal around the mouth of the bottle was not secure, the edge of the seal appeared to have been burned and the inside of the cap appeared to have had some sort of liquid in it, he said.
Police authorities immediately notified ShopKo and a call was issued to stores nationwide to pull the medication.
Meanwhile, Paul Teitell, supervising investigator with the FDA in Salt Lake urges anyone purchasing over-the-counter medication to carefully examine the container for "any evidence of it having been previously opened.
ShopKo officials said the damaged bottle and its contents have been sent to the federal Food and Drug Administration's laboratory in Cincinnati. Authorities will try to determine whether the damage was the result of tampering or a possible manufacturing defect, Kresin said.
Locally, ShopKo officials are asking all customers who bought either ShopKo brand aspirin or non-aspirin pain relievers - regardless of product lot number - to return them to a local ShopKo store for a refund or replacement with another product.
The lot number of the damaged product is 010129 with an expiration date of November 1993. That number is found on both the end flap of the box and on the side of the bottle near the top.
The ShopKo scare is the latest in possible drug tampering schemes to plague the nation.
Last week, Utah retailers removed Sudafed 12-Hour capsules after cyanide-tampering in Washington State killed two people, injured a third and prompted a nationwide recall of the over-the-counter medication.
Tuesday investigators were trying to determine whether the death of the 30-year-old Washington man who told medics he had taken a Sudafed cold tablet is linked to two earlier deaths involving cyanide-laced Sudafed capsules.
Two other people in the Tacoma-Olympia area died last month after taking cyanide-laced capsules of Sudafed 12-Hour cold medication and another woman became seriously ill. Those cases prompted the drug's manufacturer, Burroughs Wellcome Co. of North Carolina, to issue a nationwide recall of the capsule medication on March 3.
A Burroughs Welcome spokesman Tuesday said historically tampering has been limited to a particular geographic area. There have been no reports of tampering in Utah.
Yet the medication remains off the shelves of local grocery stores and pharmacies. Consumers are advised to return all Sudafed 12-Hour capsules to the stores from which they were purchased. Consumers will receive a full refund, regardless of how many capsules have been used.
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Be careful
Paul Teitell, supervising investigator with the FDA in Salt Lake City urges anyone purchasing over-the-counter medication to carefully examine the container for "any evidence of it having been previously opened.
"If they do find evidence that a container has been opened, they should bring it to the attention of the store management," he said. "Don't buy it. Get another container."