Recalls / Class I
Class ID-0457-2024
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
ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1 strip), Distributed by: GALT INT'L
- 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
- 4,351 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-0457-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.