FDA Drug recall D-1103-2022
Ondansetron HCL, Tab 8 mg filmcoated, 30-count bottle, Rx only, MFG: Sandoz Pharma, NDC 65862-188-30
- FDA Drug
- Class II
- terminated
- Published 2022-06-15
On 2022-06-15 the FDA classified a Class II recall of Ondansetron HCL, Tab 8 mg filmcoated, 30-count bottle, Rx only, MFG: Sandoz Pharma, NDC 65862-188-30 by Mckesson Medical Surgical Corporate Office, citing cGMP deviations: Temperature abuse.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1103-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-04-13 |
| Published | 2022-06-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mckesson Medical Surgical Corporate Office |
| Distribution | US |
Product
Ondansetron HCL, Tab 8 mg filmcoated, 30-count bottle, Rx only, MFG: Sandoz Pharma, NDC 65862-188-30
Reason
cGMP deviations: Temperature abuse
Identifiers
| ndc | 65862-187-30 |
|---|---|
| ndc | 65862-187-05 |
| ndc | 65862-187-99 |
| ndc | 65862-187-03 |
| ndc | 65862-187-10 |
| ndc | 65862-188-30 |
| ndc | 65862-188-05 |
| ndc | 65862-188-99 |
| ndc | 65862-188-03 |
| ndc | 65862-188-10 |
| ndc | 65862-189-11 |
| code_info | McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee fo…McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1103-2022%22
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