Drug recall
2% Chlorhexidine Gluconate Cloth, equivalent to 500 mg chlorhexidine gluconate per cloth, Patient PreOperative…
FDA recall event 48733 · Class I · Sage Products Inc
Key facts
| Event ID | 48733 |
|---|---|
| Recall numbers | D-347-2008 |
| Recalling firm | Sage Products Inc |
| Product type | Drugs |
| Products | 2% Chlorhexidine Gluconate Cloth, equivalent to 500 mg chlorhexidine gluconate per cloth, Patient PreOperative Skin Preparation, Non-Sterile, packaged 2 disposable cloths per package, 24 packs per… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Microbial Contamination of Non-Sterile Product; cloths found to be contaminated with bulkholderia cepacia |
| Initiation date | Jun 27, 2008 |
| Termination date | Jan 12, 2010 |
| City | Cary |
| State | IL |
| Country | United States |
| FEI number | 1419181 |
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