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Recall Observatory FDA recall evidence

Drug 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

D-0020-2017

December 23, 2015

Class I

Product summary

Firm
Bee Xtreme
Event
Event 73167
Status
Terminated
Classification
Class I
Quantity
732 bottles
Official record key
drug-enforcement:D-0020-2017

Official wording

Reason: Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein

Code information: All Lots

Distribution pattern: Unknown

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein