D-0559-2018 Class I Terminated
FDA drug recall D-0559-2018 was initiated by A&H Focal Inc. on March 7, 2017 and is designated Class I. 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… The recall status is terminated (terminated June 14, 2019). Affected quantity: unknown.
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
GOLD VIGRA capsules, 50mg, 6-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