FDA Drug recall D-0164-2017
Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002
- FDA Drug
- Class II
- terminated
- Published 2016-12-07
On 2016-12-07 the FDA classified a Class II recall of Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002 by Cadila Pharmaceuticals, citing microbial Contamination of Non-Sterile Product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0164-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-09 |
| Published | 2016-12-07 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Cadila Pharmaceuticals |
| Distribution | n/a |
Product
Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002
Reason
Microbial Contamination of Non-Sterile Product
Identifiers
| code_info | Supplied Batch, 150N004; Exp. 08/20 Supplied Batch, 150N006; Exp. 09/20 |
|---|
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-0164-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.