Drug recall
Chlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint (473 ml), Rx Only, Distributed by: Xttrium Laboratories…
FDA recall event 77443 · Class II · Xttrium Laboratories Inc
Key facts
| Event ID | 77443 |
|---|---|
| Recall numbers | D-0938-2017 |
| Recalling firm | Xttrium Laboratories Inc |
| Product type | Drugs |
| Products | Chlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint (473 ml), Rx Only, Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056, NDC 0116-2001-16 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CGMP Deviations |
| Initiation date | Jun 1, 2017 |
| Report date | Jul 12, 2017 |
| Termination date | Feb 19, 2018 |
| City | Chicago |
| State | IL |
| Country | United States |
| FEI number | 3008436464 |
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: