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Recall Observatory FDA recall evidence

Drug product

GEC LX Laxoplex 60 capsules Dietary Supplement, 60 count bottle, Manufactured by GEC, McKinney, TX, 75070, UPC: 700580499842

D-1092-2017

May 05, 2017

Class I

Product summary

Firm
Genetic Edge Compounds LLC
Event
Event 77208
Status
Terminated
Classification
Class I
Quantity
1759 bottles ( 105, 540 capsules)
Official record key
drug-enforcement:D-1092-2017

Official wording

Reason: Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: FDA analysis found the product to tainted with undeclared anabolic steroids and steroid like substances.

Code information: All lots.

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 Supplement: FDA analysis found the product to tainted with undeclared anabolic steroids and steroid like substances.