RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN…
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
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 was recalled
RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.
- Recalling firm
- Positive Health
- Origin
- DE, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0645-2022
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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