PlainRecalls
FDA Drug Critical Class I Terminated

Cummor Natural Male Enhancement, Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Naturally Hard Supplements, Reno, NV --- UPC code #680474229116

Reported: July 19, 2017 Initiated: April 18, 2017 #D-0962-2017

Product Description

Cummor Natural Male Enhancement, Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Naturally Hard Supplements, Reno, NV --- UPC code #680474229116

Reason for Recall

Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin

Details

Recalling Firm
Organic Herbal Supply
Distribution
Nationwide via internet
Location
Roseville, CA

Frequently Asked Questions

What product was recalled?
Cummor Natural Male Enhancement, Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Naturally Hard Supplements, Reno, NV --- UPC code #680474229116. Recalled by Organic Herbal Supply.
Why was this product recalled?
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Which agency issued this recall?
This recall was issued by the FDA Drug on July 19, 2017. Severity: Critical. Recall number: D-0962-2017.