FDA recall D-1595-2020

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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2020-09-01

Report date

2020-09-30

Termination date

2022-02-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pharr, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1595-2020