FDAFDA · Food and drugs·Recall number D-0552-2018
Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign language
Published February 7, 2018 · Recall initiated: March 7, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- A&H Focal Inc.
- Distributor
- NY and NJ through six retail stores named "Asian Food Markets"
- Lot
- All Lots
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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