Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag stapled with cardboard labeling.
Reported: September 30, 2020 Initiated: September 1, 2020 #D-1595-2020
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.
Details
- Recalling Firm
- The Protein Shoppe
- Units Affected
- 21,511 tablets
- Distribution
- Nationwide in the USA
- Location
- Pharr, TX
Frequently Asked Questions
What product was recalled? ▼
Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag stapled with cardboard labeling.. Recalled by The Protein Shoppe. Units affected: 21,511 tablets.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 30, 2020. Severity: Critical. Recall number: D-1595-2020.
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