On April 13, 2022, a Class II recall was initiated for Kinevac, the brand name for Sincalide for Injection. The affected product is packaged as 5mcg per vial, with 10 vials per box, Rx only, manufactured by Bracco Diagnostics Inc. under NDC 0270-0556-15.
The recall was classified as Class II by the FDA. The stated reason for the recall is cGMP deviations involving temperature abuse. The recalling firm is McKesson Medical-Surgical Inc., Corporate Office.
According to FDA records, this recall action has a status of terminated. The record identifier for this action is D-1087-2022. No additional details about clinical outcomes or patient impact were included in the recall record.
This brief reports only the information contained in the FDA recall record. It does not state or imply that sincalide itself is unsafe beyond the scope of this specific recall action, which concerns a manufacturing and handling deviation rather than the drug's approved use.
Readers interested in general information about sincalide, including its regulatory status and other reported events, can consult the compound overview for additional context.