Drug recall
Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake…
FDA recall event 83721 · Class II · Akorn, Inc.
Key facts
| Event ID | 83721 |
|---|---|
| Recall numbers | D-1878-2019 |
| Recalling firm | Akorn, Inc. |
| Product type | Drugs |
| Products | Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product. No particulates were identified in the product… |
| Initiation date | Sep 17, 2019 |
| Report date | Oct 2, 2019 |
| Termination date | Aug 1, 2022 |
| City | Lake Forest |
| State | IL |
| Country | United States |
| FEI number | 3003102962 |
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: