Drug recall: Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira…

Class II FDA enforcement event 79238. Recall start date: 20 Feb 2018. Status in the FDA record: Terminated. Termination date: 2 Apr 2020.

Reason for recall, in the words of FDA

Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Hospira Inc. A Pfizer Company started this drug recall on 20 Feb 2018. The firm address in the FDA record is in Mcpherson, KS. FDA put the recall in Class II. FDA event 79238 has 1 product record. The first FDA enforcement report date is 14 Mar 2018. The record gives the status Terminated, with the termination date 2 Apr 2020.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide in the USA and Puerto Rico.

Recalling firm

Hospira Inc. A Pfizer Company, Mcpherson, KS.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 79238: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0576-2018	Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-20; and b) NOVAPLUS, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-25.	a) 137,975 vials; b) 40,143 vials	Class II	Terminated	14 Mar 2018

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2018: 367
Share of these events in Class II: 60%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 9

Other events of the firm

Other FDA enforcement events of Hospira Inc. A Pfizer Company
Initiated	Product (first record)	Type	Class	Records
6 Jul 2017	Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma L	Drug	Class III	1
18 May 2017	Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC	Drug	Class II	1
10 Feb 2017	METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container, Rx only, For IV Use, Hospira Inc	Drug	Class II	1
24 Jan 2017	Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous	Drug	Class I	1
30 Dec 2016	Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of thera	Device	Class II	1
16 Sep 2016	Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, I	Drug	Class II	2
4 Aug 2016	Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, H	Drug	Class I	1
28 Jul 2016	Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combinati	Device	Class II	1

Hospira Inc. A Pfizer Company: all 9 events

Official channels

FDA enforcement report D-0576-2018The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 79238. https://recallregister.com/fda/ii/79238/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide in the USA and Puerto Rico.
What quantity of product is in FDA event 79238?: The FDA record gives this quantity: a) 137,975 vials; b) 40,143 vials
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2018 have the same class?: 60% of the 367 drug events that started in 2018 are in Class II.