FDA Recalls LaBri's Body Health Atomic 60 Capsules for Sibutramine Contamination
EZWeightLossTX LLC is recalling LaBri's Body Health Atomic 60 Capsules because the product was found to contain sibutramine, an unapproved drug ingredient.
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.
Plain-English summary
EZWeightLossTX LLC is voluntarily recalling LaBri's Body Health Atomic 60 Capsules. The recall involves 4,958 bottles of the product, which were distributed nationwide. The recall covers all lots remaining within their expiration dates.
The FDA issued this recall because the product was marketed as a dietary supplement but was found to be tainted with sibutramine. Sibutramine is an unapproved drug ingredient, meaning the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Consumers who have purchased LaBri's Body Health Atomic 60 Capsules should stop using the product immediately. They should contact EZWeightLossTX LLC for further instructions on how to return the product or obtain a refund.
The recalled product
- Product
- LaBri's Body Health Atomic 60 Capsules Exclusively distributed worldwide by LaBri's Body Health.
- Manufacturer
- EZWeightLossTX LLC
- Category
- Drug — Dietary Supplement
- Affected units
- 4,958
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 remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by EZWeightLossTX LLC 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.
See all 2 products in this recall →Related recalls
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