A New Jersey company yesterday announced it was recalling 57 million condoms -- the largest such recall ever.
Ansell Personal Products of Eatontown, N.J., said that it had received consumer complaints that the condoms were breaking before their expiration dates, and asked users to return unused condoms in question for replacement.
"Although 57 million are subject to recall, it doesn't mean that 57 million are bad," said Sharon Snider of the Food and Drug Administration, which regulates condoms as medical devices.
The agency received just eight complaints of breakage. But the company could not predict which of the condoms, which were formulated with a specific vulcanizing agent, would be faulty. "To be prudent, they along with the FDA decided to recall all of the affected lots," Snider said. Since the condoms only deteriorated over time, they would have passed the FDA standards of proof of effectiveness at the time of manufacture, Snider said.
The flawed condoms, which tend to break at the tip, were of concern to the agency because "if condoms break that means they may not adequately protect against pregnancy or sexually transmitted diseases," said Snider, who added no condom should be used after its expiration date.
The company did not return calls seeking comment, but in a statement, regional director Kerry Hoffman said the company was taking the step to ensure that "only the safest possible product is available to the customer."
The company recommended that its customers check their condoms' expiration dates, which can be found on the individual wrapper and on the package's end flap or back panel. The lots that have been recalled include: LifeStyles Ultra Sensitive with Spermicide with the expiration date October 1997. LifeStyles Assorted Colors with Spermicide with expiration dates October 1997 through June 1998. LifeStyles Spermicidally Lubricated, expiration dates October 1997 through October 1998. LifeStyles Vibra-Ribbed with Spermicide and Extra Strength with Spermicide, expiration dates October 1997 through April 2000. Prime Spermicidally Lubricated, expiration dates October 1997 through February 2000. Contempo Power Play with Spermicide, October 1997 through February 2000. Contempo Intensity Assorted Colors with Spermicide, expiration date November 1997.
Consumers with questions about the condoms should call the company at 1-800-883-3434 between 8 a.m. and 5:30 p.m. CDT, or simply return the products to Ansell Incorporated, Consumer Relations Dept., 1500 Industrial Road, Dothan, Ala. 36303.
The company has issued various recalls covering more than 360,000 condoms since 1990, according to records on the FDA's World Wide Web site.