FDA Drug recall D-1497-2016
Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454…
- FDA Drug
- Class II
- terminated
- Published 2016-09-14
On 2016-09-14 the FDA classified a Class II recall of Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454… by Teva North America, citing CGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1497-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-17 |
| Published | 2016-09-14 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva North America |
| Distribution | US |
Product
Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454 NDC # 0703-7226-01 (20 mL- Multi-dose Vial), NDC # 0703-72263-03 (10 Multi-dose Vials per carton)
Reason
CGMP Deviations
Identifiers
| code_info | All Lots Within Expiry Lot # 2930614, 2940614, 2950614 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1497-2016%22
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