Home / Recalls / Positive Health / D-0645-2022

D-0645-2022 Class I Terminated

Recalled by Positive Health — Wilmington, DE

Recall Details

Product Type: Drugs
Report Date: March 2, 2022
Initiation Date: February 10, 2022
Termination Date: June 3, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5,500 cartons

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.

Distribution Pattern

Product was distributed nationwide via the internet through Amazon Marketplace.

Code Information

Lot # 48658908, Exp. date 09/09/2023