Zero Xtreme branded Nutritional Supplement Recall [US]


US FlagUS/Silver Spring: Zero Xtreme branded Nutritional Supplement Recall [US]Zero Xtreme, a Marathon, Florida establishment, recalls certain batch/lots of Zero Xtreme branded Nutritional Supplement Capsules due to suspected presence of Sibutramine, a controlled substance under FDA regulation that was marketed as an appetite suppressant but withdrawn from the US market in 2010 due to suspected increased risks of Cardiovascular Events and Stroke, all serious health and safety hazards.

FDA: http://ht.ly/InAy30mgeRW

Direct link: https://www.fda.gov/Safety/Recalls/ucm623503.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following over-the-counter (“OTC”) drugs are subject to this recall:

  • Zero Xtreme branded Nutritional Supplement Capsules, sold as a diet pill/appetite suppressant and packaged in gray aluminum bottles with gray aluminum caps, 30 capsules per bottle. The recalled Zero Xtreme capsules were sold with a batch/lot 1220062085 and an expiry date of 03/2020. Zero Xtreme Supplements were distributed nationwide over the Web from the Web site http://www.fatburnerszone.com.

==> No barcodes, UPCs, item numbers or other identification numbers were listed with this recall notification.

According to the FDA, medications containing Sibutramine were marketed as appetite suppressants. Sibutramine has been associated with increased risk of Cardiovascular Events and Stroke and has been withdrawn from the market in several countries and regions including Australia, Canada, China, the European Union, Hong Kong, India, Mexico, New Zealand, the Philippines, Thailand, the United Kingdom, and the United States. Although Sibutramine was withdrawn from the US market in October 2010, it remains available in some countries.

If you believe you have purchased or have in your possession any of the recalled Zero Xtreme branded Nutritional Supplement Capsules, please do not consume them directly nor use them as an ingredient in another dish or preparation. Instead, return the Supplements to the store or online outlet where you purchased them for a full refund.

If you have any questions about this recall, please contact Zero Xtreme at 1-305-741-2562 from 8:00 AM to 5:00 PM Eastern Standard Time, Monday to Friday.

==> To see other recalls and notifications caused by suspected contaminated, adulterated or mislabeled Diet Capsules, please search for “diet” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by suspected Sibutramine contamination, please search for “Sibutramine” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Zero Xtreme, please search for “Zero Xtreme” using the Search Box at the top of this page.

___________________________________________________________

More information about this recall:
Recalls Direct RIN: 10734-2018
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe food or drug you purchased in the US [external: new window opens]:
==> http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm
Search for a recalled food or drug on the US FDA Web archive [external: new window opens]:
==> http://www.fda.gov/Safety/Recalls/ArchiveRecalls/default.htm

We welcome your feedback:
Want to e-mail or share this recall?
==> Simply use the “Share this” options below.
Is this recall relevant to you? Please let us know!
==> Click on the “Like” button below.
E. & O. E.

___________________________________________________________

Advertisements
%d bloggers like this: