January 22, 2001Neo Concept Aller Relief
Wellesley, MA (SafetyAlerts) - BMK International said
today it 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.
Notice of this product warning was
sent via email to SafetyAlerts
subscribers January 22, 2001. For more information regarding the SafetyAlerts free
email alert service please click here.
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