Drug recall
LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine…
FDA recall event 84179 · Class II · Fagron, Inc
Key facts
| Event ID | 84179 |
|---|---|
| Recall numbers | D-0533-2020 |
| Recalling firm | Fagron, Inc |
| Product type | Drugs |
| Products | LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4 g, Ephinephrine Bitartrate - 180 mg, Tetracaine Hydrochloride - 500 mg, Sodium… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Microbial contamination of non-sterile product. |
| Initiation date | Oct 31, 2019 |
| Report date | Dec 11, 2019 |
| Termination date | Nov 6, 2020 |
| City | Saint Paul |
| State | MN |
| Country | United States |
| FEI number | 1000174332 |
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: