The Washington Post
Wyeth Accused of Secret Recall
Infant Formula Covertly Pulled From Shelves, Philippines Says
The Philippine government’s accusation of a secret product recall by Wyeth comes during a battle in the country’s Supreme Court that pits Manila against infant-formula makers.
The Philippines yesterday accused Wyeth, a drug and healthcare company in Madison, N.J., of trying last year to remove and destroy batches of infant formula that had rust on the cans without telling the government and alerting the public.
“Wyeth should have notified us when they withdrew the affected goods from the market. But they only notified us as an afterthought,” said Joshua Ramos, deputy director of the Bureau of Food and Drugs in Manila, adding that the company came to the government only after the information about the recall was posted on the Internet.
Kevin Wiggins, a spokesman for Wyeth in the United States, said there was no reason to inform the Philippine food and drug agency because the rust had been found only on the product’s packaging and was “purely cosmetic.” The rust hadn’t affected the formula, Wiggins said.
He confirmed that Wyeth destroyed some cans of the powdered formula and removed others from the market from May to July 2006, but he said Wyeth alerted the government this spring about the results of its internal investigation and considered the matter closed. He said he did not know how many cans had been recalled.
On Tuesday, the Bureau of Food and Drugs ordered Wyeth to recall more cans of formula, which could number in the millions, according to the company. Wiggins said Wyeth is working with the government on how best to proceed and which products need to be recalled.
The company said in a statement yesterday that a routine quality inspection in July 2006 “showed that some cans had minute rust specks on the outer rim” and “a few units were retrieved for cosmetic reasons.”
Wyeth didn’t receive reports of health problems related to the product and reported that to the Philippine health officials, the company said.
It isn’t clear whether the rust posed a threat to infants’ health. “It depends on the level. We don’t have the level of contamination,” said Alessandro Iellamo, a consultant for the breast-feeding program in the Philippines with the World Health Organization. “But it’s not even clear” whether rust was the only contaminant, he said, “because they destroyed the evidence.”
The allegations come as Wyeth and other formula makers square off against the Philippine government in a Supreme Court case over a law that aims to restrict the marketing of formula. The Pharmaceutical & Healthcare Association of the Philippines, an industry group that represents multinational phar- maceutical companies, including Wyeth, is fighting the Philippine health department’s efforts to extend a ban on promoting formula to mothers with children under 1 to include children under 2.
Wiggins said Wyeth strictly complies with the WHO’s code on breast-feeding and that the attempt to extend the ban is misguided.