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Recall Observatory FDA recall evidence

Drug product

Forever Beautiful INFINITY, capsules, 300mg in 60-count bottles, 900 Commonwealth Place, Ste 104, Virginia Beach, VA

D-0993-2015

November 03, 2014

Class I

Product summary

Firm
REFA Enterprises, LLC
Event
Event 69729
Status
Terminated
Classification
Class I
Quantity
92 bottles
Official record key
drug-enforcement:D-0993-2015

Official wording

Reason: Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein

Code information: UPC CODE: 633090804649 Exp unknown

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein