Drug recall
Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC…
FDA recall event 87051 · Class II · Akorn, Inc.
Key facts
| Event ID | 87051 |
|---|---|
| Recall numbers | D-0221-2021 |
| Recalling firm | Akorn, Inc. |
| Product type | Drugs |
| Products | Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-241-16 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Defective container: Customer complaints for oral solution leaking from bottles. |
| Initiation date | Dec 28, 2020 |
| Report date | Jan 20, 2021 |
| Termination date | Aug 9, 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: