Could cause temporary or reversible harm; serious harm is unlikely.
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
| Brand name | LEVETIRACETAM |
| Generic name | LEVETIRACETAM |
| Active ingredient(s) | LEVETIRACETAM |
| Distributed by / for | Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 |
| NDC | 65862-247-08 |
| Full product label | Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, NDC 65862-247-08 |
| Recalling firm | Aurobindo Pharma USA Inc. |
| Distribution | Nationwide within the United States |
| Quantity | 8040 units |
| Recall initiated | 2020-03-18 |
| Report date | 2020-04-22 |
| Recall completed | 2024-03-25 |
| Recall number | D-1233-2020 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | East Windsor NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗