Drug recall
Fagron, Pentravan Base 2.5 Kg, Article number: 802486. RX only, For prescription compounding, Oil-in-water…
FDA recall event 68896 · Class II · Fagron, Inc
Key facts
| Event ID | 68896 |
|---|---|
| Recall numbers | D-1496-2014, D-1497-2014, D-1498-2014 |
| Recalling firm | Fagron, Inc |
| Product type | Drugs |
| Products | Fagron, Pentravan Base 2.5 Kg, Article number: 802486. RX only, For prescription compounding, Oil-in-water emulsion, PLO gel alternative, Preserved and fragrance-free, Manufactured by; Fagron, Inc…, Fagron, Pentravan Plus Base 2.5 Kg, Article number: 804749. RX only, For prescription compounding, Oil-in-water emulsion base alternative to PLO gel, Added emulsifier ad viscosity-enhancing agent for…, Fagron, Phytobase Cream, 500 g, Article number: 802156. RX only, For prescription compounding Natural self-emulsifying oil-in water vehicle for oil-solvents ingredients. Contains Phytosomes (Plant Oil… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold. |
| Initiation date | Jul 24, 2014 |
| Report date | Aug 6, 2014 |
| Termination date | Oct 21, 2014 |
| City | Saint Paul |
| State | MN |
| Country | United States |
| FEI number | 1000174332 |
At a glance
- 1–9 Products in this recall
- 10–99 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: