D-0247-2018 Class I Terminated
FDA drug recall D-0247-2018 was initiated by Blue Fusion Natural on November 29, 2017 and is designated Class I. 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… The recall status is terminated (terminated December 6, 2018). Affected quantity: 300 pill cards.
Recall Details
- Product Type
- Drugs
- Report Date
- February 7, 2018
- Initiation Date
- November 29, 2017
- Termination Date
- December 6, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 300 pill cards
Product Description
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.
Distribution Pattern
Nationwide
Code Information
All lots