D-1092-2017 Class I Terminated
FDA drug recall D-1092-2017 was initiated by Genetic Edge Compounds LLC on May 5, 2017 and is designated Class I. Reason for recall: 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. The recall status is terminated (terminated April 5, 2018). Affected quantity: 1759 bottles ( 105, 540 capsules).
Recall Details
- Product Type
- Drugs
- Report Date
- August 23, 2017
- Initiation Date
- May 5, 2017
- Termination Date
- April 5, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1759 bottles ( 105, 540 capsules)
Product Description
GEC LX Laxoplex 60 capsules Dietary Supplement, 60 count bottle, Manufactured by GEC, McKinney, TX, 75070, UPC: 700580499842
Reason for Recall
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.
Distribution Pattern
Nationwide
Code Information
All lots.