FDA Recall D-0970-2017
Organic Herbal Supply · Roseville, CA
Class I — life-threatening Terminated 325 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
ZRECT for Women Herbal Dietary Supplement Capsules, 500 mg, supplied in 30 count packages, Distributed by Organic Herbal Supply, Roseville, CA --- UPC Code 680474229055
Reason for recall
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Recall record
- Recall number
D-0970-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide via internet
- Recall initiated
- 2017-04-18
- Classified by FDA Center
- 2017-07-11
- FDA published
- 2017-07-19
- Terminated
- 2018-03-09
- Recalling firm
- Organic Herbal Supply
- Firm location
- Roseville, CA