The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-148-2013·Announced 2013-02-13

Globe All Wellness Recalls Slim Xtreme Capsules Containing Unapproved Sibutramine

Globe All Wellness is recalling Slim Xtreme Herbal Slimming Capsules because testing revealed the presence of sibutramine, an unapproved and withdrawn drug.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric. Additionally, the product contains sibutramine, a drug withdrawn for safety reasons, posing a significant health risk.

Plain-English summary

Globe All Wellness, LLC is recalling 40,400 bottles of Slim Xtreme Herbal Slimming Capsules. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Testing confirmed that the capsules contain sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons. The presence of this substance makes the product an unapproved new drug.

The recalled product is supplied in 30-count bottles. The recall includes all lots of Slim Xtreme manufactured overseas, which are identified by a black ink stamp on the bottom of the bottle in the format "MFD: XX.XX.20XX EXP: XX.XX.20XX". The products were distributed nationwide, in Puerto Rico, and internationally to Barbados, Brazil, Canada, Cyprus, Ecuador, France, Germany, Israel, Mexico, and the Netherlands.

Consumers who have purchased Slim Xtreme Herbal Slimming Capsules should stop using the product immediately. They should contact Globe All Wellness, LLC at 877.842.9873 or visit www.diet66.com for further instructions on how to return the product or obtain a refund.

The recalled product

Product
SLIM XTREME Herbal Slimming Capsule, supplied in 30-count bottles. Another Product Forumulated and Distributed By: Globe All Wellness, LLC Hollywood, FL 33020 www.diet66.com Inquires Call 877.842.9873
Manufacturer
Globe All Wellness, LLC
Category
Drug — Dietary Supplement
Hazard
Affected units
40,400

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • which were manufactured overseas
  • are being recalled.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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