Recalls / Class I
Class ID-0965-2017
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
RECTALIS 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 680474228782
- Affected lot / code info
- All lots and package sizes
Why it was recalled
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Recalling firm
- Firm
- Organic Herbal Supply
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 8303 Sierra College Blvd Ste 128, Roseville, California 95661-9420
Distribution
- Distribution pattern
- Nationwide via internet
Timeline
- Recall initiated
- 2017-04-18
- FDA classified
- 2017-07-11
- Posted by FDA
- 2017-07-19
- Terminated
- 2018-03-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0965-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.