Ummzy, LLC: Drug Recall
Recall #D-0663-2021 · 03/30/2021
Class I: Dangerous
Recall Details
- Recall Number
- D-0663-2021
- Classification
- Class I
- Product Type
- Drug
- Recalling Firm
- Ummzy, LLC
- Status
- Terminated
- Date Initiated
- 03/30/2021
- Location
- Palisades Park, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 364 boxes/10 capsules per box
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.
Product Description
Shogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, Made in USA, UPC 118122030185
Distribution Pattern
USA Nationwide
Other Recalls by Ummzy, LLC
- Class I: Dangerous 03/30/2021
- Class I: Dangerous 03/30/2021
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.