CLASS II Drug recall · Reported 19 Jul 2017 · FDA Enforcement Report

5% Dextrose Injection, USP Viaflex recalled by Baxter Healthcare

Baxter Healthcare is recalling 5% Dextrose Injection, USP Viaflex, distributed nationwide in the US. The recall was initiated on 6 Jul 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: P361618, Exp 09/30/18;

NDC0338-0017, 0338-0023

Quantity recalled54,528 bags

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-0972-2017
FDA event ID: 77676
Recalling firm: Baxter Healthcare, Deerfield, IL
Brand: Dextrose
Manufacturer: Baxter Healthcare Corporation
Classification: Class II
Status: Terminated
Recall initiated: 6 Jul 2017
FDA classified: 11 Jul 2017
Reported: 19 Jul 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

6 Jul 2017	Recall initiated by company
11 Jul 2017	Classified by FDA	+5 days
19 Jul 2017	Published in enforcement report	+8 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: Bags have the potential to leak.

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

5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B0089, NDC: 0338-0017-38

Where it was distributed

Nationwide, Puerto Rico and Saudi Arabia

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility: Bags have the potential to leak.

Which lots are affected?

Lot: P361618, Exp 09/30/18;

Where was it sold?

Nationwide, Puerto Rico and Saudi Arabia

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 77676

Reported	Class	Recall	Company	Reason	Where
19 Jul 2017	CLASS II	0.9% Sodium Chloride Injection, USP Viaflex Container recalledSodium Chloride	Baxter Healthcare	Sterility	Nationwide

More recalls from Baxter Healthcare

All 577

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30 Sep 2026Device	CLASS II	PRO+ 36" MRS Surface, mattress recalled by Baxter Healthcare	Baxter Healthcare	Packaging Defects	Nationwide
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30 Sep 2026Device	CLASS II	Volara System Volara, HC, NA recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	PRO+ 40" MRS Surface, mattress recalled by Baxter Healthcare	Baxter Healthcare	Packaging Defects	Nationwide
16 Sep 2026Drug	CLASS I	Dextrose Injection, USP, 70 % recalled by Baxter Healthcare	Baxter Healthcare	Particulate Matter	Nationwide

Other Dextrose recalls

All 44

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS I	Dextrose Injection, USP, 70 % recalled by Baxter Healthcare	Baxter Healthcare	Particulate Matter	Nationwide
29 Apr 2026Drug	CLASS II	Dextrose Injection recalled by B Braun MedicalDextrose	B Braun Medical	Sterility	Nationwide
15 Apr 2026Drug	CLASS II	5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose	Fresenius Kabi USA	Sterility	Nationwide
15 Apr 2026Drug	CLASS II	5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose	Fresenius Kabi USA	Sterility	Nationwide
15 Apr 2026Drug	CLASS II	5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose	Fresenius Kabi USA	Sterility	Nationwide