Drug product
RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.
D-0645-2022
Product summary
- Firm
- Positive Health
- Event
- Event 89606
- Status
- Terminated
- Classification
- Class I
- Quantity
- 5,500 cartons
- Official record key
drug-enforcement:D-0645-2022
Official wording
Reason: 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.
Code information: Lot # 48658908, Exp. date 09/09/2023
Distribution pattern: Product was distributed nationwide via the internet through Amazon Marketplace.
Derived failure modes
-
Unknown
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.