Drug recall
Male Enhancer capsules, 60 capsule bottles, UPC Code: 982010061205
FDA recall event 58303 · Class I · U.S.A Far Ocean Group Llc
Key facts
| Event ID | 58303 |
|---|---|
| Recall numbers | D-1461-2011, D-1462-2011 |
| Recalling firm | U.S.A Far Ocean Group Llc |
| Product type | Drugs |
| Products | Male Enhancer capsules, 60 capsule bottles, UPC Code: 982010061205, X-Hero capsules with English label, 1 capsule pack, no UPC Code, 10 capsule bottles, UPC Code: 689087070995; X-Hero capsules with Chinese and/or English Label, 8 capsule bottles, UPC Code… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Marketed without an approved NDA/ANDA; FDA lab analysis found product to contains sulfosildenafil, an analogue of sildenafil., Marketed without an approved NDA/ANDA; FDA lab analysis found product to contain tadalafil, an FDA approved drug used to treat erectile dysfunction (ED), making the product an unapproved new drug. |
| Initiation date | Mar 27, 2011 |
| Termination date | Aug 14, 2012 |
| City | Alhambra |
| State | CA |
| Country | United States |
| FEI number | 2000029973 |
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