FDA Recall D-1092-2017
Genetic Edge Compounds LLC · McKinney, TX
Class I — life-threatening Terminated 335 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Recall record
- Recall number
D-1092-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2017-05-05
- Classified by FDA Center
- 2017-08-15
- FDA published
- 2017-08-23
- Terminated
- 2018-04-05
- Recalling firm
- Genetic Edge Compounds LLC
- Firm location
- McKinney, TX