Why it was recalled
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.
Product description
GEC LX Laxoplex 60 capsules Dietary Supplement, 60 count bottle, Manufactured by GEC, McKinney, TX, 75070, UPC: 700580499842
Lot numbers, UPCs & expiration codes
All lots.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1092-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 5, 2017
- FDA report date
- Aug 23, 2017
- Quantity
- 1759 bottles ( 105, 540 capsules)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Genetic Edge Compounds LLC
Original FDA data
Every field from FDA enforcement report D-1092-2017, exactly as published.
Show all FDA fields
- City
- McKinney
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 77208
- Address
- 2305 Brandywine
- Code information
- All lots.
- Postal code
- 75070-4563
- Report date
- Aug 23, 2017
- Product type
- Drugs
- Recall number
- D-1092-2017
- Classification
- Class I
- Recalling firm
- Genetic Edge Compounds LLC
- Product quantity
- 1759 bottles ( 105, 540 capsules)
- Termination date
- Apr 5, 2018
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- GEC LX Laxoplex 60 capsules Dietary Supplement, 60 count bottle, Manufactured by GEC, McKinney, TX, 75070, UPC: 700580499842
- Distribution pattern
- Nationwide
- Recall initiation date
- May 5, 2017
- Initial firm notification
- Press Release
- Center classification date
- Aug 15, 2017