Could cause temporary or reversible harm; serious harm is unlikely.
Presence of foreign substance (screw)
| Brand name | LEVETIRACETAM |
| Generic name | LEVETIRACETAM ORAL |
| Active ingredient(s) | LEVETIRACETAM |
| Distributed by / for | Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Jeedimetla,Hyderabad - 500 055, India |
| NDC | 31722-574-47 |
| Full product label | Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Jeedimetla,Hyderabad - 500 055, India, NDC 31722-574-47 |
| Recalling firm | Hetero Labs, Ltd. - Unit III |
| Distribution | NJ |
| Quantity | 4050 bottles |
| Recall initiated | 2017-10-12 |
| Report date | 2017-12-06 |
| Recall completed | 2020-09-03 |
| Recall number | D-0099-2018 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Hyderabad N/A India |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗