FDA Recall D-1595-2020
The Protein Shoppe · Pharr, TX
Class I — life-threatening Terminated 525 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Recall record
- Recall number
D-1595-2020- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide in the USA
- Recall initiated
- 2020-09-01
- Classified by FDA Center
- 2020-09-24
- FDA published
- 2020-09-30
- Terminated
- 2022-02-08
- Recalling firm
- The Protein Shoppe
- Firm location
- Pharr, TX