FDA posts press releases and other notices of recalls 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.

BMK International Voluntarily Recalls Neo Concept Aller Relief Because of Possible Health Risk

NEWS RELEASE



Contact:  BMK International
          781-235-9999

For Immediate Release

WELLESLEY, MA - January 19, 2001 - BMK International is voluntarily recalling Neo Concept Aller Relief after receiving notification from the FDA that the product contains trace amounts of aristolochic acid. Aristolochic acid is a potent carcinogen and nephrotoxin found in certain plants and botanicals. Products that contain arstolochic acid have been associated with several occurrences of kidney failure in Europe. The use of aristolochic acid containing products has also been linked to the increase risk of kidney cancer in people who have consumed it.

Aller Relief was distributed nationwide to licensed health care practitioners, and retail outlets. Aller Relief is packaged in 30-ct. and 90-.ct. capsules. The lot numbers covered in this recall are 30-ct. and 90-ct.: #003480, #0006480.

No complaints or reports illnesses have been reported to date.

The recall is a result of the FDA notification that recommended manufacturers test their products that contain herbs that may be contaminated with aristolochic acid. The company was informed by the FDA that the product contains trace amounts of aristolochic acid and thus is conducting a voluntary recall. The company has reformulated the Aller Relief product to ensure that in the future no herb in the formula contains or may be adulterated with aristolochic acid. The reformulated product will available shortly.

Consumers with questions can call telephone: (781) 235-9999. Consumers should return the product to the place of purchase for a full cash refund.

FDA/Website Management Staff
Web page created by tg 2001-JAN-22.