Positive Health: Drug Recall
Recall #D-0645-2022 · 02/10/2022
Class I: Dangerous
Recall Details
- Recall Number
- D-0645-2022
- Classification
- Class I
- Product Type
- Drug
- Recalling Firm
- Positive Health
- Status
- Terminated
- Date Initiated
- 02/10/2022
- Location
- Wilmington, DE, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,500 cartons
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.
Product Description
RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.
Distribution Pattern
Product was distributed nationwide via the internet through Amazon Marketplace.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.