D-0663-2021 Class I Terminated
FDA drug recall D-0663-2021 was initiated by Ummzy, LLC on March 30, 2021 and is designated Class I. Reason for recall: Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been est… The recall status is terminated (terminated June 9, 2022). Affected quantity: 364 boxes/10 capsules per box.
Recall Details
- Product Type
- Drugs
- Report Date
- July 28, 2021
- Initiation Date
- March 30, 2021
- Termination Date
- June 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 364 boxes/10 capsules per box
Product Description
Shogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, Made in USA, UPC 118122030185
Reason for Recall
Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Distribution Pattern
USA Nationwide
Code Information
All lots within expiry.