D-1080-2020 Class I Terminated
FDA drug recall D-1080-2020 was initiated by Y-O Management LLC, dba Natural Remedy Store on March 16, 2020 and is designated Class I. 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 The recall status is terminated (terminated November 10, 2021). Affected quantity: 19156 packets estimated distributed.
Recall Details
- Product Type
- Drugs
- Report Date
- April 8, 2020
- Initiation Date
- March 16, 2020
- Termination Date
- November 10, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19156 packets estimated distributed
Product Description
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
Distribution Pattern
Distributed in GA and TX
Code Information
All lots remaining within expiry.