FDA Recall D-0562-2022
ABC Sales 1 Inc · Monsey, NY
Class I — life-threatening Terminated 24 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
MAC DADDY RED Capsules, packaged in 10-count blisters per carton, ASIN B07TLDZLY2, UPC 742137 605191.
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.
Recall record
- Recall number
D-0562-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Product was distributed nationwide in the USA via Amazon Marketplace.
- Recall initiated
- 2022-02-08
- Classified by FDA Center
- 2022-02-17
- FDA published
- 2022-02-23
- Terminated
- 2022-03-04
- Recalling firm
- ABC Sales 1 Inc
- Firm location
- Monsey, NY