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ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1 strip), Dist...

FDA Recall #D-0457-2024 — Class I — March 19, 2024

Recall #D-0457-2024 Date: March 19, 2024 Classification: Class I Status: Ongoing

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.

Recalling Firm

Pyramids Wholesale Inc. — Los Angeles, CA

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

4,351 pieces

Distribution

Nationwide in the USA

Code Information

All lots

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

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