Why it was recalled
Marketed Without An Approved NDA/ANDA: product tainted with undeclared sildenafil, an FDA approved drug for the treatment of male erectile dysfunction. The presence of sildenafil in Leopard Miracle Honey renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Product description
LEOPARD Miracle Honey packaged in a wooden box, UPC 8 699415 910534, containing 12 sachets 180Gr / 6.36 Oz, each 1 Sachet 15 gr / 0.53 Oz is labeled as LEOPARD Miracle of Honey, UPC 8 699415 912859, Manufactured in Turkey, www leopardhoneytr.com.
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
Nationwide in the USA.
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-1135-2019
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 5, 2019
- FDA report date
- Apr 17, 2019
- Quantity
- 83 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- USA LESS Inc.
Original FDA data
Every field from FDA enforcement report D-1135-2019, exactly as published.
Show all FDA fields
- City
- Brooklyn
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 82336
- Address
- 1864 Sterling Pl
- Code information
- All lots
- Postal code
- 11233-4710
- Report date
- Apr 17, 2019
- Product type
- Drugs
- Recall number
- D-1135-2019
- Classification
- Class I
- Recalling firm
- USA LESS Inc.
- Product quantity
- 83 boxes
- Termination date
- Jan 10, 2024
- Reason for recall
- Marketed Without An Approved NDA/ANDA: product tainted with undeclared sildenafil, an FDA approved drug for the treatment of male erectile dysfunction. The presence of sildenafil in Leopard Miracle Honey renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- LEOPARD Miracle Honey packaged in a wooden box, UPC 8 699415 910534, containing 12 sachets 180Gr / 6.36 Oz, each 1 Sachet 15 gr / 0.53 Oz is labeled as LEOPARD Miracle of Honey, UPC 8 699415 912859, Manufactured in Turkey, www leopardhoneytr.com.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Mar 5, 2019
- Initial firm notification
- Letter
- Center classification date
- Apr 16, 2019