Drug recall
Alcohol-Free Mouthwash, a blue liquid in a 4 fl. oz. (118 mL) plastic bottle, 60 bottles per case, and in a 32…
FDA recall event 48433 · Class II · Hydrox Chemical Co
Key facts
| Event ID | 48433 |
|---|---|
| Recall numbers | D-293-2008, D-294-2008, D-295-2008 |
| Recalling firm | Hydrox Chemical Co |
| Product type | Drugs |
| Products | Alcohol-Free Mouthwash, a blue liquid in a 4 fl. oz. (118 mL) plastic bottle, 60 bottles per case, and in a 32 fl. oz. plastic bottle, 12 bottles per case; the mouthwash was distributed under the…, Alcohol-Free Mouthwash, a yellow liquid in a 2 fl. oz. plastic bottle, 96 bottles per case, 4 fl. oz. (118 mL) plastic bottle, 24 bottles per case and 60 bottles per case, and in a 16 fl. oz. plastic…, Mouthwash with 2.5% Alcohol, a yellow liquid in a 4 oz. (118 mL) plastic bottle, 60 bottles per case; the mouthwash was distributed under the following labels: 1) Hydrox Fresh Moment Mouthwash and… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CGMP Deviations. The mouthwash was manufactured under conditions where by it may be contaminated with the bacteria Burkholderia cepacia. |
| Initiation date | May 23, 2008 |
| Termination date | Jul 12, 2009 |
| City | Elgin |
| State | IL |
| Country | United States |
| FEI number | 1419821 |
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