PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: November 21, 2018 Initiated: October 15, 2018 #D-0246-2019

Product Description

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

Reason for Recall

Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine

Details

Recalling Firm
Zero Xtreme USA
Units Affected
16 bottles
Distribution
Nationwide within the USA.
Location
Aventura, FL

Frequently Asked Questions

What product was recalled?
Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA. Recalled by Zero Xtreme USA. Units affected: 16 bottles.
Why was this product recalled?
Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine
Which agency issued this recall?
This recall was issued by the FDA Drug on November 21, 2018. Severity: Moderate. Recall number: D-0246-2019.