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Recall Observatory FDA recall evidence

Drug product

LaBri's Body Health Atomic 60 Capsules Exclusively distributed worldwide by LaBri's Body Health.

D-0121-2018

July 24, 2017

Class I

Product summary

Firm
EZWeightLossTX LLC
Event
Event 77817
Status
Terminated
Classification
Class I
Quantity
4958 bottles
Official record key
drug-enforcement:D-0121-2018

Official wording

Reason: Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.

Code information: All lots remaining within expiry.

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.