FDA recall D-1092-2017

Genetic Edge Compounds LLC · Class I · drug

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.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2017-05-05
Report date
2017-08-23
Termination date
2018-04-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
McKinney, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1092-2017