Drug recall
Prolatis' (Polygonati Annum), Dietary Supplement Capsules, in 2ct blister packs, 16ct and 40ct bottles…
FDA recall event 56571 · Class I · Prolatis
Key facts
| Event ID | 56571 |
|---|---|
| Recall numbers | D-106-2011 |
| Recalling firm | Prolatis |
| Product type | Drugs |
| Products | Prolatis' (Polygonati Annum), Dietary Supplement Capsules, in 2ct blister packs, 16ct and 40ct bottles, labeled as "Distributed by Prolatis Inc" or "Distributed by Hyper Interactive Media LLC" |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Marketed Without an Approved NDA/ANDA; product found to contain sulfoaildenafil, an analogue of sildenafil, an active ingredient used for the treatment of male Erectile Dysfunction. |
| Initiation date | Aug 9, 2010 |
| Termination date | Jul 24, 2012 |
| City | Draper |
| State | UT |
| Country | United States |
| FEI number | 3008487769 |
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