FDA-Drug2018-02-07Class I

Miraculous Evil Root capsules, 1200 mg, 6-count bottle, labeling is in foreign language

A&H Focal Inc.
Hazard

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

Sold states
NY and NJ through six retail stores named "Asian Food Markets"
Affected count
unknown
Manufactured in
119 Linwood Ave, Staten Island, NY, United States
Products
Miraculous Evil Root capsules, 1200 mg, 6-count bottle, labeling is in foreign language

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0554-2018

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