Orange, CA, United States
Blue Fusion Natural recalls
1 recall recorded since 2018, most recently on 29 November 2017. 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
- 29 November 2017
- Terminated
- 6 December 2018
- Reason
- Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0247-2018
- BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5
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.