Recall Record

Monsey, NY, United States

ABC Sales 1 Inc recalls

1 recall recorded since 2018, most recently on 8 February 2022. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)1

Terminated Class I Drugs

Recall started
8 February 2022
Terminated
4 March 2022
Reason
Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.
Distribution
Product was distributed nationwide in the USA via Amazon Marketplace.
Initiated
Voluntary: Firm initiated
Recall numbers
D-0562-2022, D-0563-2022

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.