Drug recall
Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 mL unit does cups (barcode…
FDA recall event 86717 · Class I · Lohxa LLC
Key facts
| Event ID | 86717 |
|---|---|
| Recall numbers | D-0111-2021 |
| Recalling firm | Lohxa LLC |
| Product type | Drugs |
| Products | Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 mL unit does cups (barcode 7016602715), packaged in 50-count unit dose cups per carton, Rx only, Distributed by: Lohxa… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia lata. |
| Initiation date | Oct 28, 2020 |
| Report date | Dec 9, 2020 |
| Termination date | Mar 15, 2022 |
| City | Worcester |
| State | MA |
| Country | United States |
| FEI number | 3014188920 |
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 · Source date: