D-0968-2017 Class I Terminated
FDA drug recall D-0968-2017 was initiated by Organic Herbal Supply on April 18, 2017 and is designated Class I. Reason for recall: Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin The recall status is terminated (terminated March 9, 2018).
Recall Details
- Product Type
- Drugs
- Report Date
- July 19, 2017
- Initiation Date
- April 18, 2017
- Termination Date
- March 9, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
BIGnHARD Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY ---- UPC Code 680474229086
Reason for Recall
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Distribution Pattern
Nationwide via internet
Code Information
All lots and package sizes