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Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-00...

FDA Recall #D-0246-2019 — Class II — October 15, 2018

Recall #D-0246-2019 Date: October 15, 2018 Classification: Class II Status: Terminated

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

Recalling Firm

Zero Xtreme USA — Aventura, FL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

16 bottles

Distribution

Nationwide within the USA.

Code Information

Lot: 1220062085 Exp. 03/2020

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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