FDAFDA · Food and drugs·Recall number D-0645-2022
RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.
Published March 2, 2022 · Recall initiated: February 10, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Positive Health
- Distributor
- Product was distributed nationwide via the internet through Amazon Marketplace.
- Lot
- Lot # 48658908, Exp. date 09/09/2023
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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