Drug recall
Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Manufactured by: SUM…
FDA recall event 87624 · Class I · Ummzy, LLC
Key facts
| Event ID | 87624 |
|---|---|
| Recall numbers | D-0662-2021, D-0663-2021, D-0664-2021 |
| Recalling firm | Ummzy, LLC |
| Product type | Drugs |
| Products | Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Manufactured by: SUM MARKETING LLC, Made in USA UPC 746695241860, Shogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, Made in USA, UPC 118122030185, Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in USA, UPC 617135894680. |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| 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… |
| Initiation date | Mar 30, 2021 |
| Report date | Jul 28, 2021 |
| Termination date | Jun 9, 2022 |
| City | Palisades Park |
| State | NJ |
| Country | United States |
| FEI number | 3018304838 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: