ABC Sales 1 Inc: Drug Recall

Recall #D-0562-2022 · 02/08/2022

Class I: Dangerous

Recall Details

Recall Number
D-0562-2022
Classification
Class I
Product Type
Drug
Recalling Firm
ABC Sales 1 Inc
Status
Terminated
Date Initiated
02/08/2022
Location
Monsey, NY, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
565 cartons

Reason for Recall

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.

Product Description

MAC DADDY RED Capsules, packaged in 10-count blisters per carton, ASIN B07TLDZLY2, UPC 742137 605191.

Distribution Pattern

Product was distributed nationwide in the USA via Amazon Marketplace.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.