Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag stapled with cardboard labeling.

FDA recall notice · announced September 30, 2020 · The Protein Shoppe

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Notes

Distribution: Nationwide in the USA
Lot/code information: All lots.
Quantity: 21,511 tablets
Status: Terminated
Products in this recall event:
- Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag stapled with cardboard labeling. (D-1595-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.