Drug recall
RE Pramoxine-HC (hydrocortisone/chloroxylenol/pramoxine HCl), Otic drops, 10 mg/1 mg/10 mg, 10 mL dropper…
FDA recall event 54548 · Class III · River's Edge Pharmaceuticals, LLC
Key facts
| Event ID | 54548 |
|---|---|
| Recall numbers | D-378-2010 |
| Recalling firm | River's Edge Pharmaceuticals, LLC |
| Product type | Drugs |
| Products | RE Pramoxine-HC (hydrocortisone/chloroxylenol/pramoxine HCl), Otic drops, 10 mg/1 mg/10 mg, 10 mL dropper bottle, Rx Only, Manufactured for: River's Edge Pharmaceuticals, LLC, Suwanee, GA 30024, NDC… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product Lacks Stability |
| Initiation date | Aug 28, 2009 |
| Termination date | Apr 5, 2011 |
| City | Suwanee |
| State | GA |
| Country | United States |
| FEI number | 3004738265 |
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