Shogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, Made in USA, UPC 118122030185
Reported: July 28, 2021 Initiated: March 30, 2021 #D-0663-2021
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.
Details
- Recalling Firm
- Ummzy, LLC
- Units Affected
- 364 boxes/10 capsules per box
- Distribution
- USA Nationwide
- Location
- Palisades Park, NJ
Frequently Asked Questions
What product was recalled? ▼
Shogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, Made in USA, UPC 118122030185. Recalled by Ummzy, LLC. Units affected: 364 boxes/10 capsules per box.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 28, 2021. Severity: Critical. Recall number: D-0663-2021.
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