D-0638-2022 Class I Terminated
FDA drug recall D-0638-2022 was initiated by Celebrate Today on February 8, 2022 and is designated Class I. 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… The recall status is terminated (terminated March 29, 2022). Affected quantity: 500 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- February 23, 2022
- Initiation Date
- February 8, 2022
- Termination Date
- March 29, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 500 cartons
Product Description
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.
Distribution Pattern
Product was distributed nationwide in the USA via Amazon Marketplace
Code Information
Lot # DK1027, Exp. 08/01/2023