FDA Recall D-0571-2018
A&H Focal Inc. · Staten Island, NY
Class I — life-threatening Terminated 829 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
MACA gold tablets, 6800 mg, 10-count bottle, labeling is in foreign language
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.
Recall record
- Recall number
D-0571-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- NY and NJ through six retail stores named "Asian Food Markets"
- Recall initiated
- 2017-03-07
- Classified by FDA Center
- 2018-02-28
- FDA published
- 2018-02-07
- Terminated
- 2019-06-14
- Recalling firm
- A&H Focal Inc.
- Firm location
- Staten Island, NY