CLASS II Drug recall · Reported 3 Dec 2014 · FDA Enforcement Report

Potassium Chloride in 5% Dextrose recalled by Hospira

Hospira is recalling Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP container, distributed nationwide in the US. The recall was initiated on 14 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 34-017-JT; Exp. 10/15 Lot # 35-100-JT; Exp. 11/15

Quantity recalled836,460 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-0278-2015
FDA event ID: 69494
Recalling firm: Hospira, Lake Forest, IL
Classification: Class II
Status: Terminated
Recall initiated: 14 Oct 2014
FDA classified: 25 Nov 2014
Reported: 3 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

14 Oct 2014	Recall initiated by company
25 Nov 2014	Classified by FDA	+42 days
3 Dec 2014	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: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

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

Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7902-09.

Where it was distributed

Nationwide, Puerto Rico, and U.S. Virgin Islands.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Which lots are affected?

Lot # 34-017-JT; Exp. 10/15 Lot # 35-100-JT; Exp. 11/15

Where was it sold?

Nationwide, Puerto Rico, and U.S. Virgin Islands.

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

10 other products · FDA event 69494

This product is part of a recall event; the main page for the event is 5% Dextrose and 0.9% Sodium Chloride Injection, USP container recalled.

Reported	Class	Recall	Company	Reason	Where
3 Dec 2014	CLASS II	5% Dextrose and 0.9% Sodium Chloride Injection, USP container recalled	Hospira	Sterility	Nationwide
3 Dec 2014	CLASS II	0.45% Sodium Chloride Injection, USP container recalled by Hospira	Hospira	Sterility	Nationwide
3 Dec 2014	CLASS II	Sterile Water for Injection, USP container recalled by Hospira	Hospira	Sterility	Nationwide
3 Dec 2014	CLASS II	0.9% Sodium Chloride Injection, USP container recalled by Hospira	Hospira	Sterility	Nationwide
3 Dec 2014	CLASS II	5% Dextrose Injection, USP container recalled by Hospira	Hospira	Sterility	Nationwide
3 Dec 2014	CLASS II	5% Dextrose and 0.45% Sodium Chloride Injection, USP container recalled	Hospira	Sterility	Nationwide
3 Dec 2014	CLASS II	Lactated Ringer's Injection, USP container recalled by Hospira	Hospira	Sterility	Nationwide
3 Dec 2014	CLASS II	Lactated Ringer's and 5% Dextrose Injection recalled by Hospira	Hospira	Sterility	Nationwide
3 Dec 2014	CLASS II	Normosol-R Multiple Electrolytes Injection Type 1, USP container recalled	Hospira	Sterility	Nationwide
3 Dec 2014	CLASS II	Normosol-R pH 7.4 Multiple Electrolytes Injection Type recalled	Hospira	Sterility	Nationwide

More recalls from Hospira

All 225

Reported	Class	Recall	Company	Reason	Where
31 May 2017Drug	CLASS I	Infant 25% Dextrose Injection recalled by HospiraDextrose	Hospira	Particulate Matter	Nationwide
18 Jan 2017Device	CLASS II	Minibore Extension Set with Spin Lock Collar, Non-DEHP, Latex-Free recalled	Hospira	Other	Nationwide
14 Dec 2016Drug	CLASS III	5% Lidocaine HCL and 7.5% Dextrose Injection, USP Single-dose ampule recalled	Hospira	Potency & Assay	PR
30 Nov 2016Drug	CLASS II	Fentanyl Citrate Injection, USP, 100 mcg Fentanyl recalled by Hospira	Hospira	Sterility	Nationwide
28 Sep 2016Device	CLASS II	LifeCare PCA 3, PCA recalled by Hospira	Hospira	Device Malfunction	Nationwide

Other Potassium Chloride recalls

All 23

Reported	Class	Recall	Company	Reason	Where
26 Nov 2025Drug	CLASS I	Potassium Chloride Inj., 20 mEq total in Flexible Container recalledPotassium Chloride	Otsuka ICU Medical	Other	Nationwide
26 Nov 2025Drug	CLASS I	Potassium Chloride Inj., 10 mEq total in Flexible Container recalledPotassium Chloride	Otsuka ICU Medical	Other	Nationwide
19 Mar 2025Drug	CLASS I	Potassium Chloride Inj., 20 mEq total in flexible container recalledPotassium Chloride	ICU Medical	Labeling Errors	Nationwide
19 Mar 2025Drug	CLASS I	Potassium Chloride Inj., 10 mEq total recalled by ICU MedicalPotassium Chloride	ICU Medical	Other	Nationwide
12 Feb 2025Drug	CLASS II	Potassium Chloride Extended-Release Tablets, USP, 10 mEq recalledPotassium Chloride	The Harvard Drug Group	Potency & Assay	Nationwide