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FDA (Drug enforcement)Recalled 2022-04-13closedclass ii

Mckesson Medical-Surgical Inc. Corporate Office: Kinevac (Sincalide for Injection), 5mcg per vial, 10 vials per box, Rx only, MFG: Bracco Diagnostics Inc., NDC 0270-0556-15

Is my product affected?

Kinevac (Sincalide for Injection), 5mcg per vial, 10 vials per box, Rx only, MFG: Bracco Diagnostics Inc., NDC 0270-0556-15

  • Brand KINEVAC

Check against the official notice below — it lists the full affected range.

What happened

McKesson Medical-Surgical Inc. is recalling Kinevac (Sincalide for Injection), 5 micrograms per vial in boxes containing 10 vials, due to cGMP deviations involving temperature abuse. The recalled product was distributed nationwide in the United States, with a total of 5 boxes affected. The manufacturer, Bracco Diagnostics Inc., produced this prescription-only medication.

Because McKesson Medical-Surgical is unable to identify the specific lot numbers received by individual customers, the company is notifying consignees through letters that include the distribution date and the dates when affected product may have been shipped to them. The record does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

cGMP deviations: Temperature abuse

Details from the source

Reason for recall: cGMP deviations: Temperature abuse Distribution: USA nationwide. Quantity: 5 boxes Lot/code info: 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.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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