D-0457-2024 Class I Ongoing
FDA drug recall D-0457-2024 was initiated by Pyramids Wholesale Inc. on March 19, 2024 and is designated Class I. Reason for recall: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. The recall status is ongoing. Affected quantity: 4,351 pieces.
Recall Details
- Product Type
- Drugs
- Report Date
- May 1, 2024
- Initiation Date
- March 19, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,351 pieces
Product Description
ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1 strip), Distributed by: GALT INT'L
Reason for Recall
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Distribution Pattern
Nationwide in the USA
Code Information
All lots