FDA recalls Kinevac injectable drug due to manufacturing temperature deviation
FDA is recalling Kinevac (Sincalide for Injection), a prescription injectable drug distributed nationwide, due to cGMP deviations involving temperature abuse during manufacturing.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a risk-of-harm product (prescription intravenous medication) subject to manufacturing temperature abuse. Although no illnesses or injuries have been reported, temperature deviation could compromise product stability or integrity.
Plain-English summary
FDA is recalling Kinevac (Sincalide for Injection) supplied as 5 micrograms per vial, 10 vials per box, manufactured by Bracco Diagnostics Inc. and distributed by McKesson Medical-Surgical Inc. The recall involves 5 boxes distributed nationwide. This is a prescription injectable medication administered intravenously.
The recall was initiated due to cGMP (current Good Manufacturing Practice) deviations related to temperature abuse during manufacturing.
McKesson Medical-Surgical Inc. has notified customers of the recall. The company is unable to identify specific lot numbers received by individual customers, though each customer received notification with the distribution date and the dates when impacted product may have been shipped.
Patients and healthcare providers should contact McKesson Medical-Surgical Inc. or their healthcare provider with questions about this recall.
The recalled product
- Product
- KINEVAC (SINCALIDE)
- Brand
- KINEVAC
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable / Diagnostic
- Affected units
- 5
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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