Drug & medication recalls Moderate risk

Zero Xtreme Dietary Supplement capsules recalled over undeclared sibutramine

Recall date
October 15, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Zero Xtreme USA recalls Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA
Recall number
D-0246-2019
FDA classification
Class II
Brand / firm
Zero Xtreme USA
Sold / distributed
Nationwide within the USA.

Why it was recalled

Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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