Brooklyn, NY, United States
USA LESS Inc. recalls
1 recall recorded since 2018, most recently on 5 March 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)1
Terminated Class I Drugs
- Recall started
- 5 March 2019
- Terminated
- 10 January 2024
- Reason
- 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.
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1135-2019
- 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 Turke
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.