Class I
Terminated
Miraculous Evil Root capsules, 1200 mg, 6-count bottle, labeling is in foreign language
- Company
- A&H Focal Inc.
- Recall Initiated
- March 7, 2017
- Posted
- February 7, 2018
- Recall Number
- D-0554-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- unknown
- Firm Location
- Staten Island, NY, United States
Reason for Recall
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.
Distribution
NY and NJ through six retail stores named "Asian Food Markets"
Lot / Code Info
All Lots
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