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TOPIC: Niwali Tejocote Capsules and Niwali Tejocote Pieces by Global Mix: Recall - Because of Possible Health Risk

AUDIENCE: Consumer, Patient, Health Care Professional, Pharmacy, Cardiology

ISSUE: Global Mix is recalling niwali Tejocote Capsules (90 capsules, Herbal Supplement) and niwali Tejocote Pieces (90 Day Supply, Herbal Supplement) because FDA analysis has determined that the products appear to be Thevetia peruviana, or yellow oleander. All parts of the yellow oleander plant are known to contain cardiac glycosides, which are highly toxic to humans and animals. Ingestion of yellow oleander can cause severe or even fatal neurologic, gastrointestinal, and cardiovascular adverse health effects. Symptoms may include nausea, vomiting, dizziness, diarrhea, abdominal pain, changes in heart rhythm, arrhythmia, and more.

The products were distributed nationwide within the United States through eBay.com and Everymarket.com. 

No illnesses or adverse events have been reported to the company to date in connection with the recalled products.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: The product being recalled is marketed as a herbal dietary supplement.

RECOMMENDATIONS: 

• Consumers who have consumed the product and who have concerns about their health should contact a healthcare provider.

• Consumers who have purchased niwali Tejocote Capsules or niwali Tejocote Pieces should stop using them immediately and should not consume any remaining product.

• Consumers should return the products to the place of purchase for a full refund or contact the company at the number below to arrange a refund. Consumers with questions may contact Global Mix Inc. Customer Service at (646) 419-5884 or by email at office@unitedlegalexperts.com.

• Further information about this recall is available at www.globalmixinc.com.

Health care professionals, consumers and patients 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.
• Download the form or call 1-800-332-1088 to request a reporting form, then complete it and return it to the address on the form or submit it by fax to 1-800-FDA-0178.

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