NDC 65219-468

Sodium chloride 9 mg per 1 mL injection, solution

Where it's made

Factory	Where	Role	Last FDA inspection
Fresenius Kabi USA, LLC	Wilson, NC, United States	Makes it and tests it	Problems found, fixed voluntarilyFeb 13, 2026 · 5 inspections
Fresenius Medical Care North America	Ogden, UT, United States	Makes it, tests it, packages it, labels it and sterilizes it	Serious problems, FDA actionMar 6, 2026 · 8 inspections, 1 with FDA action

Mar 11, 2026 · Class II · Fresenius Kabi USA, LLC
Lack of Assurance of Sterility
Lots: Batch# 6402372, 6402374, Exp Date: 08/31/2026; Batch# 6402437, Exp Date: 10/31/2026.
Mar 11, 2026 · Class II · Fresenius Kabi USA, LLC
Lack of Assurance of Sterility
Lots: Batch# 6402299, 6402300, 6402301, 6402302, 6402303, Exp Date: 01/31/2027; Batch# 6402305, 6402398, Exp Date: 02/28/2027; Batch# 6402467, Exp Date: 04/30/2027; Batch# 6402577, 6402578, Exp Date: 06/30/2027.
Mar 11, 2026 · Class II · Fresenius Kabi USA, LLC
Lack of Assurance of Sterility
Lots: Batch# 23SU10008, Exp Date: 12/31/2026; Batch# 24JU10003, Exp Date: 07/31/2027; Batch# 24LU10011, 24LU10012, Exp Date: 9/30/2027; Batch# 6402273, 6402275, Exp Date: 01/31/2028; Batch# 6402420, 6402421, 6402422, 6402423, Exp Date: 03/31/2028; Batch# 6402473, 6402474, 6402475, 6402476, 6402485, Exp D…
Mar 11, 2026 · Class II · Fresenius Kabi USA, LLC
Lack of Assurance of Sterility
Lots: Batch# 24LU10013, 24LU10014, Exp Date: 09/30/2027; Batch# 24NU10001, 24NU10002, Exp Date: 10/31/2027.

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

Generic drug: Sodium Cation: every company that makes it
Form: injection, solution, intravenous
Strength: 9 mg per 1 mL
Approval: ANDA ANDA207310
On the market since: Sep 19, 2017
Package NDCs: 65219-468-05 65219-468-50
Official label: DailyMed (National Library of Medicine), updated Jan 4, 2024

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