FDA Recall D-1080-2020
Y-O Management LLC, dba Natural Remedy Store · San Antonio, TX
Class I — life-threatening Terminated 604 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement Manufactured For: Natural Remedies San Antonio, TX, USA 1(877)543-3501
Reason for recall
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction
Recall record
- Recall number
D-1080-2020- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Distributed in GA and TX
- Recall initiated
- 2020-03-16
- Classified by FDA Center
- 2020-04-04
- FDA published
- 2020-04-08
- Terminated
- 2021-11-10
- Recalling firm
- Y-O Management LLC, dba Natural Remedy Store
- Firm location
- San Antonio, TX