NDC 0270-0556
Kinevac 5 ug per 5 mL injection, powder, lyophilized, for solution
On the label: Bracco Diagnostics Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Bachem AG | Bubendorf, Switzerland | Makes the active ingredient | Problems found, fixed voluntarilyAug 16, 2024 · 4 inspections |
| Fresenius Kabi USA, LLC | Grand Island, NY, United States | Makes it and tests it | Problems found, fixed voluntarilyOct 13, 2023 · 14 inspections, 2 with FDA action |
| Jubilant HollisterStier LLC | Spokane, WA, United States | Makes it and tests it | No problems foundMar 5, 2021 · 13 inspections, 1 with FDA action |
Recalls
- Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Lots: 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.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Sincalide: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 5 ug per 5 mL
- Approval
- NDA NDA017697
- On the market since
- Jul 21, 1976
- Package NDCs
0270-0556-15- Official label
- DailyMed (National Library of Medicine), updated Oct 18, 2023
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