PlainRecalls
FDA Drug Moderate Class II Terminated

Ondansetron HCL, Tab 8 mg filmcoated, 30-count bottle, Rx only, MFG: Sandoz Pharma, NDC 65862-188-30

Reported: June 15, 2022 Initiated: April 13, 2022 #D-1103-2022

Product Description

Ondansetron HCL, Tab 8 mg filmcoated, 30-count bottle, Rx only, MFG: Sandoz Pharma, NDC 65862-188-30

Reason for Recall

cGMP deviations: Temperature abuse

Details

Units Affected
2 bottles/500 tablets each
Distribution
USA nationwide.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
Ondansetron HCL, Tab 8 mg filmcoated, 30-count bottle, Rx only, MFG: Sandoz Pharma, NDC 65862-188-30. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 2 bottles/500 tablets each.
Why was this product recalled?
cGMP deviations: Temperature abuse
Which agency issued this recall?
This recall was issued by the FDA Drug on June 15, 2022. Severity: Moderate. Recall number: D-1103-2022.