FDA Recall D-0645-2022
Positive Health · Wilmington, DE
Class I — life-threatening Terminated 113 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.
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.
Recall record
- Recall number
D-0645-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Product was distributed nationwide via the internet through Amazon Marketplace.
- Recall initiated
- 2022-02-10
- Classified by FDA Center
- 2022-03-04
- FDA published
- 2022-03-02
- Terminated
- 2022-06-03
- Recalling firm
- Positive Health
- Firm location
- Wilmington, DE