RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.
Reported: March 2, 2022 Initiated: February 10, 2022 #D-0645-2022
Product Description
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.
Details
- Recalling Firm
- Positive Health
- Units Affected
- 5,500 cartons
- Distribution
- Product was distributed nationwide via the internet through Amazon Marketplace.
- Location
- Wilmington, DE
Frequently Asked Questions
What product was recalled? ▼
RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.. Recalled by Positive Health. Units affected: 5,500 cartons.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 2, 2022. Severity: Critical. Recall number: D-0645-2022.
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