D-0571-2018 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 7, 2018
- Initiation Date
- March 7, 2017
- Termination Date
- June 14, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- unknown
Product Description
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.
Distribution Pattern
NY and NJ through six retail stores named "Asian Food Markets"
Code Information
All Lots