Recalls / Class I
Class ID-0455-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
SILVERBACK XXX POWER MALE ENHANCEMENT, 2 fl. oz., UPC 8 700470 032762
- Affected lot / code info
- All lots
Why it was recalled
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Recalling firm
- Firm
- Pyramids Wholesale Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 464 E 4th St, N/A, Los Angeles, California 90013-1604
Distribution
- Quantity
- 7 pieces
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-03-19
- FDA classified
- 2024-04-22
- Posted by FDA
- 2024-05-01
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0455-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.