May 2017 FDA Recall Drug by Genetic Edge Compounds Llc
D-1092-2017 - Marketed Without An Approved NDA/ANDA
This Class I drug recall was voluntarily initiated by Genetic Edge Compounds Llc on May 5, 2017 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1092-2017
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.
05-05-2017
08-23-2017
1759 bottles ( 105, 540 capsules)
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Genetic Edge Compounds LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
04-05-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
GEC LX Laxoplex 60 capsules Dietary Supplement, 60 count bottle, Manufactured by GEC, McKinney, TX, 75070, UPC: 700580499842
Batch or Lot Expiration Information
Lot# All lots.
