It's Easy to Miss the Memo on Product Recalls
The FDA and American Medical Optic had the challenge of recalling almost 28 million bottles of Complete MoisturePLUS Multipurpose Contact Lens Solution.
The FDA and American Medical Optic had the challenge of recalling almost 28 million bottles of Complete MoisturePLUS Multipurpose Contact Lens Solution.
Off the Shelf
Contact-lens solution is only one of several products regulated by the FDA to be recalled within the past two months:
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What is the FDA's role in product recalls?
What happens when a dangerous product is recalled and you don't get the message? That happened to James Millard Wilson, a young art student in Baltimore.
Wilson started wearing contact lenses in April. He first realized something was wrong at the end of June. He blamed it on his summer job.
"My eyes had been really irritated," he says. "I was working as a house painter and I thought it was paint fumes, dust and scraping, but my contacts got worse and worse."
And his eyes hurt.
"It was a very sharp, stinging pain. Often I wasn't able to open my left eye," he says.
The next day he made it to work.
"But I was in a lot of pain," Wilson says. "I showed up and a co-worker took one look at my eyes and said 'Man, you have to go to the hospital.'"
Blurry Nightmare
So he went to Sinai Hospital and some swift detective work by the ophthalmologists there revealed the problem: Wilson had a rare infection in his eye, probably related to the contact-lens cleaning solution he had been using – American Medical Optic's (AMO) Complete MoisturePLUS Multipurpose Contact Lens Solution.
The company had recalled the product, but Wilson was still using a bottle he had gotten from his eye doctor in April.
Tim Ulatowski of the Food and Drug Administration says that the problem with the product became apparent around the end of May. On Friday of the Memorial Day weekend, the FDA received a warning from the Centers for Disease Control and Prevention. Data showed a sudden upswing in a rare infection called Acanthamoeba keratitis, caused by an amoeba. There were 138 cases in 35 states and Puerto Rico.
People who used the contact-lens cleaning solution were at least seven times more likely to get the infection than other contact-lens wearers. If not treated soon enough, the infection can lead to blindness.
"We contacted AMO, and to their credit, AMO took very quick action with their product," Ulatowski says.
The word went out that same day. The FDA, CDC and manufacturer AMO posted recall notices on their Web sites and sent out press releases.
AMO contacted health care professionals and stores via the Internet, phone and mail. Ulatowski says the agency's press office went into high gear.
"We rely on the media to a greater or lesser extent depending on the particular recall we're working on," he says.
But consumer activists say that's not enough.
Missing the Memo
"Now the problem with that, of course, is that if you're not reading, watching or listening in the right place, you're gonna miss the news," says Donald Mays, senior director for public safety planning for Consumer Reports magazine.
Many people did miss the announcement. The company checked and found stores that still had Complete MoisturePLUS Multipurpose solution on their shelves.
Reports of new infections came in to the CDC. The FDA had to send out a second press release a couple of weeks ago. Ulatowski said the challenge was the size of the recall — 28 million bottles since May 2005.
"It's difficult to reach into everyone's medicine cabinet to determine that that product has been controlled and returned or disposed of by the consumer," he says.
But art student James Wilson never got the word. He has no Internet connection in the warehouse loft where he lives. TV reception is bad, and the local alternative weekly paper he reads didn't contain a notice of the recall.
For people who do have Internet connections, and are motivated, there are informative Web sites at your service. Fred Richman at the Office of Enforcement in the FDA, shows off the FDA Web site at www.fda.gov.
"As you'll see, the headlines, the latest recalls are right up at the top under 'FDA News,'" he says.
Drill down a little and you can get a full description of the recalled products: names and lot numbers, and even photos of some of the products.
But without an Internet connection, Wilson likely won't go back to contact lenses.
"No, no way," he says. "This whole experience left me a little wary about contacts."
He's going to stick with the nice, new tortoiseshell glasses he just bought.
Where Does the FDA Fit In?
Several federal departments and agencies share responsibility for making sure that products sold in the United States are safe.
Toy safety, for example, is mostly monitored by the Consumer Product Safety Commission. The United States Department of Agriculture checks meat quality, and the National Highway Traffic Safety Administration regulates cars. Oversight of drugs, cosmetics, medical devices and most food falls to the Food and Drug Administration.
One Web site, www.recalls.gov, tracks recent actions taken by all those agencies. While steps that lead to a product recall can differ a bit from agency to agency, the FDA's plan, as outlined below, is typical:
What are recalls? Any of several types of actions taken to remove a product from the market because it may be harmful to the consumer. This can mean simply halting distribution of the product and removing it from store shelves. Reimbursing customers for products already purchased is not required by the FDA.
Who makes the recall? The manufacturer or distributor may take the initiative, or the FDA can request or order the recall.
What is an FDA request like? If the FDA learns that a product is defective and the company hasn't already addressed the problem on its own, the FDA may suggest a recall. Companies usually comply.
How does the FDA get a drug off the market? The FDA can require the recall of infant formula, and certain drugs and medical devices. With other FDA-regulated products, the agency informs the manufacturer of its concerns. If the manufacturer refuses to take action, the FDA can issue a press release citing the problems.
Who enforces a recall? The FDA sets guidelines under the Code of Federal Regulations that leaves responsibility for product recalls to firms, including follow-up checks to ensure that the recalls are successful. (Sometimes the FDA does its own spot checks of stores).
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