D-1595-2020 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 30, 2020
- Initiation Date
- September 1, 2020
- Termination Date
- February 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21,511 tablets
Product Description
Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag stapled with cardboard labeling.
Reason for Recall
Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug fro which the safety and efficacy have not been established and therefore subject to recall.
Distribution Pattern
Nationwide in the USA
Code Information
All lots.