MAC DADDY PURPLE Capsules, packaged in 10-count blisters per carton, ASIN B08Z63Z4QK, UPC 742137 ...
FDA Recall #D-0563-2022 — Class I — February 8, 2022
Product Description
MAC DADDY PURPLE Capsules, packaged in 10-count blisters per carton, ASIN B08Z63Z4QK, UPC 742137 605764.
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.
Recalling Firm
ABC Sales 1 Inc — Monsey, NY
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
336 cartons
Distribution
Product was distributed nationwide in the USA via Amazon Marketplace.
Code Information
Lot # 1230005, Exp. date 03/30/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated