Drug recall
Pandora, Sexual Enhancer for Women, 1 capsule per blister pack (UPC Number 094922014948), Rock Hard…
FDA recall event 57538 · Class I · Rock Hard Laboratories, LLC
Key facts
| Event ID | 57538 |
|---|---|
| Recall numbers | D-818-2011, D-819-2011 |
| Recalling firm | Rock Hard Laboratories, LLC |
| Product type | Drugs |
| Products | Pandora, Sexual Enhancer for Women, 1 capsule per blister pack (UPC Number 094922014948), Rock Hard Laboratories, Alpharetta, GA 30005., RockHard Weekend, Sexual Performance Enhancer for Men, sold 1 capsule per blister pack (UPC Number 094922147257), 3 count bottles (UPC Number 094922208705) and 8 count bottles, (UPC Number… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Marketed Without an Approved NDA/ANDA: Laboratory analysis identified an analogue of Sildenafil, an ingredient in a FDA approved drug to treat Erectile Dysfunction in the products. That makes the… |
| Initiation date | Dec 22, 2010 |
| Termination date | Jul 24, 2012 |
| City | Roswell |
| State | GA |
| Country | United States |
| FEI number | 3007845693 |
At a glance
- 1–9 Products in this recall
- 1–9 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