sábado, 11 de mayo de 2013

Safety Alerts for Human Medical Products > Atriphen dietary supplement (Xymogen brand): Recall - Potential Allergic Reaction Due to Milk and Soy

Safety Alerts for Human Medical Products > Atriphen dietary supplement (Xymogen brand): Recall - Potential Allergic Reaction Due to Milk and Soy

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Atriphen dietary supplement (Xymogen brand): Recall - Potential Allergic Reaction Due to Milk and Soy

AUDIENCE: Consumer, Health Professional
ISSUE: The nutraceutical company, Xymogen, (Orlando, FL) and FDA, are notifying consumers and health professionals of the recall of Atriphen, a product sold for the support of healthy joint function, because it contains the undeclared allergens, soy and milk.
BACKGROUND: Xymogen learned that Atriphen might contain the two allergens, immediately discontinued sale of the product and had a third-party laboratory test the product to confirm the presence of the allergens.
RECOMMENDATION: People who have an allergy or severe sensitivity to either milk or soy run the risk of serious or life-threatening allergic reaction if they consume this product. Although there have been no reported allergic reactions or any adverse events in connection with the product to date, consumers are urged to return this product for a full refund. 
More information is available at www.xymogen.com. Consumers may email pr@xymogen.com for comments or inquiries.
Consumers and health professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download%20form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the complete MedWatch Safety Alert, including a link to the Press Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351525.htm

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