BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5
Reported: February 7, 2018 Initiated: November 29, 2017 #D-0247-2018
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.
Details
- Recalling Firm
- Blue Fusion Natural
- Units Affected
- 300 pill cards
- Distribution
- Nationwide
- Location
- Orange, CA
Frequently Asked Questions
What product was recalled? ▼
BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5. Recalled by Blue Fusion Natural. Units affected: 300 pill cards.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 7, 2018. Severity: Critical. Recall number: D-0247-2018.
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