FDA Recall D-0963-2017
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 Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Roseville, CA --- UPC Code 852675999451
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-0963-2017- 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