Envy Me Recalls LaBri's Body Health Atomic Due to Undeclared Sibutramine
Envy Me is recalling LaBri's Body Health Atomic capsules because the product contains undeclared Sibutramine and was marketed without an approved NDA/ANDA.
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 corresponds to a Critical severity score of 5 according to the rubric.
Plain-English summary
Envy Me is recalling LaBri's Body Health Atomic, 60 capsules, because the product contains undeclared Sibutramine. The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The product was sold nationwide through internet sales. No foreign consignees were reported. The recall includes all lot codes, manufacturing codes, and expiration dates.
Consumers should stop using the product and contact Envy Me for further instructions or a refund.
The recalled product
- Product
- LaBri's Body Health Atomic, 60 capsules
- Manufacturer
- Envy Me
- Category
- Drug — Dietary Supplement
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)
- All lot codes
- manufacturing codes and expiration dates.
Distribution
Distributed nationwide across the United States.
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