FDA Recall D-0630-2022
Your Favorite Shop · Jackson, NJ
Class I — life-threatening Terminated 49 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
THE RED PILL, EXTRA STRENGTH capsules, 800 mg, packaged in 10-count blisters packaged in a carton, ASIN B0847BSQQ5, Barcode X002G5GMJ1.
Reason for recall
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Recall record
- Recall number
D-0630-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Product was distributed nationwide in the USA via the internet through Amazon Marketplace.
- Recall initiated
- 2022-02-08
- Classified by FDA Center
- 2022-02-23
- FDA published
- 2022-02-23
- Terminated
- 2022-03-29
- Recalling firm
- Your Favorite Shop
- Firm location
- Jackson, NJ