Drug recall
Select Brand Nite Time Cold/Flu Relief, (acetaminophen 1000mg, dextromethorphan HBr 30mg, doxylamine succinate…
FDA recall event 33821 · Class III · Vintage Pharmaceuticals LLC
Key facts
| Event ID | 33821 |
|---|---|
| Recall numbers | D-012-6 |
| Recalling firm | Vintage Pharmaceuticals LLC |
| Product type | Drugs |
| Products | Select Brand Nite Time Cold/Flu Relief, (acetaminophen 1000mg, dextromethorphan HBr 30mg, doxylamine succinate 12.5mg and pseudoephedrine HCl 60mg), 6 fl oz (177mL), Cherry Flavor, over the counter… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Label fails to declare correct dye colors as FD&C blue #1 and FD&C red #40 |
| Initiation date | Aug 31, 2005 |
| Termination date | Jul 25, 2008 |
| City | Huntsville |
| State | AL |
| Country | United States |
| FEI number | 1000524784 |
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