FDA Recall D-0638-2022
Celebrate Today · Brentwood, NY
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
RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5.
Reason for recall
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Recall record
- Recall number
D-0638-2022- 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
- 2022-02-28
- FDA published
- 2022-02-23
- Terminated
- 2022-03-29
- Recalling firm
- Celebrate Today
- Firm location
- Brentwood, NY