Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Nationwide Alert On B-Sure Pregnancy Test
FOR IMMEDIATE RELEASE -- Oak Park, MI -- March 25, 2005 -- Harmony Brands, Oak Park, Michigan, a national distributor of health, cosmetic and other consumer products, is voluntarily recalling its B-Sure brand One-Step Home Pregnancy Test., because its safety and efficacy can no longer be assured.
Consumers who have unused & unexpired B-Sure brand One-Step Home Pregnancy Test in their possession should not use the product and should return the product to the point of purchase for a refund. Additionally, women who have used the test may wish to contact their health care provider to verify the test results.
Harmony also announced that there have been no reports of failures of the product, and there have been no reports of injury or illness associated with their use. FDA has been apprised of this action.
The tests which are the subject of the recall were sold throughout the United States in a variety of retail outlets, including Dollar Stores and convenience stores. The tests can be identified by the product label notation “B-sure” pregnancy test. Additional information identifying the product can be found on the Harmony Brands website at www.harmonybrands.com.
A Harmony spokesman stated: “Even though we have had no reports of any deficiencies in the product, to insure strict compliance with FDA regulations, we believe this recall is in the best interest of our customers. We regret any inconvenience caused by the recall, and will take all necessary steps to insure the complete satisfaction of purchasers of Harmony Brand products.”