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Recall Observatory FDA recall evidence

Drug product

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

D-1595-2020

September 01, 2020

Class I

Product summary

Firm
The Protein Shoppe
Event
Event 86377
Status
Terminated
Classification
Class I
Quantity
21,511 tablets
Official record key
drug-enforcement:D-1595-2020

Official wording

Reason: 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.

Code information: All lots.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.