Wilmington, DE, United States
Positive Health recalls
1 recall recorded since 2018, most recently on 10 February 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)1
Terminated Class I Drugs
- Recall started
- 10 February 2022
- Terminated
- 3 June 2022
- 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.
- Distribution
- Product was distributed nationwide via the internet through Amazon Marketplace.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0645-2022
- RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.