Olaax MAXILOSS Weight Advanced Recalled for Containing Unapproved Sibutramine
Olaax International is recalling MAXILOSS Weight Advanced capsules because they contain sibutramine, an unapproved drug removed from the U.S. market for safety reasons.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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.
Plain-English summary
Olaax International is recalling MAXILOSS Weight Advanced, a 225 mg proprietary blend of herbs supplied in 36-count capsules in green and blue boxes. The product was formulated and distributed by Olaax Corp in Lakeland, Florida. The recall covers 600 boxes and all lots.
The recall was initiated because the product contains sibutramine, a previously approved FDA drug that was removed from the U.S. marketplace for safety reasons. Consequently, the product is considered an unapproved new drug marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The product was distributed nationwide, as well as in Puerto Rico, Venezuela, and Bolivia. Consumers should stop using the product and return it to the place of purchase for a refund or follow instructions from the recalling firm.
The recalled product
- Product
- MAXILOSS Weight Advanced, 225 mg proprietary blend of herbs, supplied in 36 count capsules in Green & Blue Boxes, Formulated and distributed by Olaax Corp, Lakeland, FL
- Manufacturer
- OLAAX International
- Category
- Drug — Dietary Supplement
- Affected units
- 600
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 (1)
- All Lots
Distribution
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