Key Takeaway

Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, FL 33180 by XTREME Z DISTRIBUTORS INC was recalled on July 2, 2015. The hazard: Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.

FDA Drug Class I Ongoing

Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, FL 33180

Recalled: July 2, 2015 ~70,350 capsules units affected D-1165-2016

Description

Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, FL 33180

Hazard / Reason

Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.

Class I: Dangerous or defective product that could cause serious health problems or death.

Class I is the most serious recall classification used by the FDA, indicating a reasonable probability of serious health consequences or death.

Products Affected

Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, FL 33180

Drugs

Company Information

XTREME Z DISTRIBUTORS INC

Aventura, FL, United States

View all 1 recalls by XTREME Z DISTRIBUTORS INC →

Distribution

Nationwide

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Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.