FDA Recall D-0247-2018
Blue Fusion Natural · Orange, CA
Class I — life-threatening Terminated 372 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5
Reason for recall
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.
Recall record
- Recall number
D-0247-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide
- Recall initiated
- 2017-11-29
- Classified by FDA Center
- 2018-02-01
- FDA published
- 2018-02-07
- Terminated
- 2018-12-06
- Recalling firm
- Blue Fusion Natural
- Firm location
- Orange, CA