Why it was recalled
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug.
Product description
APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7.
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
All product is sold to Ace Distributors, LLC in Orlando, FL, a retail store, who sells directly to owners of gas stations, convenience stores, and smoke shops where it can be further distributed 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-0667-2016
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Dec 23, 2015
- FDA report date
- Feb 24, 2016
- Quantity
- 100,000 blister cards
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nuway Distributors, LLC
Original FDA data
Every field from FDA enforcement report D-0667-2016, exactly as published.
Show all FDA fields
- City
- Orlando
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 73016
- Address
- 9020 Pecky Cypress Way
- Code information
- All lots
- Postal code
- 32836-6562
- Report date
- Feb 24, 2016
- Product type
- Drugs
- Recall number
- D-0667-2016
- Classification
- Class I
- Recalling firm
- Nuway Distributors, LLC
- Product quantity
- 100,000 blister cards
- Reason for recall
- Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7.
- Distribution pattern
- All product is sold to Ace Distributors, LLC in Orlando, FL, a retail store, who sells directly to owners of gas stations, convenience stores, and smoke shops where it can be further distributed nationwide.
- Recall initiation date
- Dec 23, 2015
- Initial firm notification
- Other
- Center classification date
- Feb 16, 2016