NDC 63323-285

Naropin 2 mg per 1 mL injection, solution

On the label: Fresenius Kabi, LLC.

Austria: 1United States: 1Norway: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Fresenius Kabi AustriaAustria 8055, AustriaMakes it, tests it and packages it Problems found, fixed voluntarilyMar 21, 2024 · 9 inspections
Fresenius Kabi USA, LLCMelrose Park, IL, United StatesMakes it and tests it Problems found, fixed voluntarilyAug 24, 2023 · 13 inspections, 2 with FDA action
HP Halden Pharma ASHalden, NorwayMakes it, tests it and packages it Problems found, fixed voluntarilyMay 10, 2023 · 7 inspections

Recalls

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Product details

Generic drug
Ropivacaine: every company that makes it
Form
injection, solution, epidural; infiltration
Strength
2 mg per 1 mL
Approval
NDA NDA020533
On the market since
Aug 4, 2009
Package NDCs
63323-285-28 63323-285-41 63323-285-53 63323-285-59 63323-285-68 63323-285-73
Official label
DailyMed (National Library of Medicine), updated Aug 15, 2024

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