CLASS II Drug recall · Reported 1 Apr 2015 · FDA Enforcement Report

0.9% Sodium Chloride Injection, USP in Viaflex recalled

Baxter Healthcare is recalling 0.9% Sodium Chloride Injection, USP in Viaflex, distributed nationwide in the US. The recall was initiated on 18 Mar 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: C929844, Exp 5/31/2015; C926873, Exp 4/30/2015; C928630, Exp 4/30/2015.

NDC0338-0043, 0338-0049

Quantity recalled597,498 units total

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0425-2015
FDA event ID: 70770
Recalling firm: Baxter Healthcare, Deerfield, IL
Brand: Sodium Chloride
Manufacturer: Baxter Healthcare Corporation
Classification: Class II
Status: Terminated
Recall initiated: 18 Mar 2015
FDA classified: 25 Mar 2015
Reported: 1 Apr 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

18 Mar 2015	Recall initiated by company
25 Mar 2015	Classified by FDA	+7 days
1 Apr 2015	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0049-03

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.

Which lots are affected?

Lot #: C929844, Exp 5/31/2015; C926873, Exp 4/30/2015; C928630, Exp 4/30/2015.

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 70770

This product is part of a recall event; the main page for the event is 5% Dextrose Injection, USP in Viaflex recalled by Baxter Healthcare.

Reported	Class	Recall	Company	Reason	Where
1 Apr 2015	CLASS II	5% Dextrose Injection, USP in Viaflex recalled by Baxter HealthcareDextrose	Baxter Healthcare	Sterility	Nationwide

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Other Sodium Chloride recalls

All 133

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS I	0.9% Sodium Chloride Injection, USP Partial Fill recalledSodium Chloride	B Braun Medical	Particulate Matter	Nationwide
9 Sep 2026Drug	CLASS I	0.9% Sodium Chloride Injection USP, Viaflex recalledSodium Chloride	Baxter Healthcare	Particulate Matter	IL
2 Sep 2026Drug	CLASS I	Lactated Ringer's Injection USP Excel container recalledLactated Ringers	B Braun Medical	Particulate Matter	Nationwide
13 May 2026Drug	CLASS I	Lactated Ringer's Injection USP container recalled by B Braun MedicalLactated Ringers	B Braun Medical	Particulate Matter	Nationwide
29 Apr 2026Drug	CLASS II	Lactated Ringer's Irrigation, Sterile, Ex only recalledLactated Ringers Irrigation	B Braun Medical	Sterility	Nationwide