Key Takeaway

Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA by Zero Xtreme USA was recalled on October 15, 2018. The hazard: Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine

FDA Drug Class II Terminated

Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA

Recalled: October 15, 2018 ~16 bottles units affected D-0246-2019

Description

Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA

Hazard / Reason

Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA

Drugs

Company Information

Zero Xtreme USA

Aventura, FL, United States

View all 1 recalls by Zero Xtreme USA →

Distribution

Nationwide within the USA.

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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.