D-0472-2017 Class I Terminated
FDA drug recall D-0472-2017 was initiated by MS Bionic on November 30, 2016 and is designated Class I. Reason for recall: Marketed without an Approved NDA/ANDA; product contains sildenafil and tadalafil which are active pharmaceutical ingredients in FDA approved drugs used to treat erectile dysfunction (ED) The recall status is terminated (terminated June 1, 2017). Affected quantity: 100 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 22, 2017
- Initiation Date
- November 30, 2016
- Termination Date
- June 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100 bottles
Product Description
MegaJex Herbal Supplement, Maximum Formula for Men, Fast acting, Increase Stamina, 20 capsules, MS Bionics, Gardena, CA
Reason for Recall
Marketed without an Approved NDA/ANDA; product contains sildenafil and tadalafil which are active pharmaceutical ingredients in FDA approved drugs used to treat erectile dysfunction (ED)
Distribution Pattern
CA
Code Information
All Lots exp. date 12/2019