Recalls / Class I
Class ID-0969-2017
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
ENHANCEROL 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
- 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-0969-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.