D-0630-2022 Class I Terminated
FDA drug recall D-0630-2022 was initiated by Your Favorite Shop on February 8, 2022 and is designated Class I. 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 unap… The recall status is terminated (terminated March 29, 2022). Affected quantity: 12,500 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
- 12,500 cartons
Product Description
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.
Distribution Pattern
Product was distributed nationwide in the USA via the internet through Amazon Marketplace.
Code Information
Lot # 26436989, Exp. date 10/30/2023