Blue Pearl Capsules Recalled for Undeclared Sildenafil
Blue Fusion Natural is recalling Blue Pearl capsules because FDA analysis found undeclared sildenafil, an unapproved drug for erectile dysfunction.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Blue Fusion Natural is recalling Blue Pearl capsules, 500mg, 1-count packets, distributed by Blue Pearl in Long Beach, CA. The product is identified by UPC 8 4704600978 5. The recall covers 300 pill cards and all lots.
The FDA determined that the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA analysis found that the capsules contain undeclared sildenafil, which is an FDA-approved drug for the treatment of erectile dysfunction. Because the product contains this undeclared active ingredient, it is considered an unapproved drug for which safety and efficacy have not been established.
The recall is classified as Class I by the FDA. The distribution pattern is listed as nationwide. Consumers who have purchased this product should stop using it and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5
- Manufacturer
- Blue Fusion Natural
- Category
- Drug — Unapproved Drug
- Affected units
- 300
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Distributed nationwide across the United States.
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