Drug recall
Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company…
FDA recall event 84427 · Class I · Lannett Company, Inc.
Key facts
| Event ID | 84427 |
|---|---|
| Recall numbers | D-0630-2020 |
| Recalling firm | Lannett Company, Inc. |
| Product type | Drugs |
| Products | Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc. Philadelphia, PA 19136, NDC 54838-0548-80 |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count. |
| Initiation date | Dec 6, 2019 |
| Report date | Dec 25, 2019 |
| Termination date | Jul 13, 2020 |
| City | Philadelphia |
| State | PA |
| Country | United States |
| FEI number | 2510865 |
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: