Oasis Dietary Supplement Capsules Recalled for Unapproved Active Ingredients
Bee Xtreme LLC is recalling Oasis Dietary Supplement Capsules because FDA analysis found the products contain sibutramine and phenolphthalein without an approved NDA or ANDA.
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 corresponds to a reasonable probability of serious adverse health consequences or death, meeting the criteria for a Critical severity score.
Plain-English summary
Bee Xtreme LLC is recalling 732 bottles of Oasis Dietary Supplement Capsules, 500 mg, 45 count bottles. The product was manufactured for Timeless Solutions and distributed by BeeXtreme LLC. The recall covers all lots of the product.
The recall was initiated because the product was marketed without an Approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA analysis determined that the capsules contain sibutramine and phenolphthalein. These are active pharmaceutical ingredients that were not declared on the product label.
Consumers who have purchased these products should stop using them immediately. The source text does not specify a geographic distribution pattern or provide specific instructions for disposal or return.
The recalled product
- Product
- Oasis Dietary Supplement Capsules, 500 mg, 45 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA
- Manufacturer
- Bee Xtreme
- Category
- Drug — Dietary Supplement
- Affected units
- 732
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
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Bee Xtreme under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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