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Recall Observatory FDA recall evidence

Drug product

Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on top bottle

D-0106-2017

July 01, 2016

Class II

Product summary

Firm
Dream Body Weight Loss
Event
Event 74588
Status
Terminated
Classification
Class II
Quantity
Unknown
Official record key
drug-enforcement:D-0106-2017

Official wording

Reason: Marketed without an approved NDA/ANDA: Undeclared sibutramine.

Code information: All lots.

Distribution pattern: United States

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without an approved NDA/ANDA: Undeclared sibutramine.