Drug product
GEC LX Laxoplex 60 capsules Dietary Supplement, 60 count bottle, Manufactured by GEC, McKinney, TX, 75070, UPC: 700580499842
D-1092-2017
Product summary
- 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
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.