FDAFDA · Food and drugs·Recall number D-1595-2020
Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag stapled with cardboard labeling.
Published September 30, 2020 · Recall initiated: September 1, 2020
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 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.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- The Protein Shoppe
- Distributor
- Nationwide in the USA
- Lot
- All lots.
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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