---
title: "Labetalol Hydrochloride Injection by Hospira: Recall - Potential For Cracked Glass At Rim Surface Of Vials"
description: "Labetalol Hydrochloride Injection by Hospira: Recall - Potential For Cracked Glass At Rim Surface Of Vials"
---

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[Medical Malpractice](https://blog.theironslawfirm.com/tag/medical-malpractice)

# Labetalol Hydrochloride Injection by Hospira: Recall - Potential For Cracked Glass At Rim Surface Of Vials

 March 02, 2018

 Written by:

 Harry Albritton

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**ISSUE**: Hospira is voluntarily recalling 3 lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial (NDC 0409-2267-20), and one lot of Labetalol Hydrochloride Injection, USP, Novaplus (NDC 0409-2267-25) to the hospital/institution level. Hospira, Inc. initiated this recall due to the discovery of cracks on the rim surface of vials for these lots, which is covered by the stopper and crimp seal.

Cracked vials may result in a lack of sterility assurance for the product. Use of or exposure to a non-sterile product may be associated with adverse events such as fever, chills, sepsis or invasive systemic infections in patients.

Product was distributed nationwide to wholesalers / retailers / hospitals in the United States and Puerto Rico from April 2017 to August 2017.

**BACKGROUND**: Labetalol Hydrochloride is an adrenergic receptor blocking agent indicated for the control of blood pressure (BP) in severe hypertension. It is administered by repeated intravenous (IV) injections or by slow IV infusion.

**RECOMMENDATION**: Hospira, Inc. has notified wholesalers/retailers/hospitals by recall letter to arrange for return of any recalled product.

Wholesalers/retailers/hospitals/institutions with an existing inventory of the lots subject to this recall should stop use and distribution of the remaining units and quarantine immediately. Healthcare Professionals in your organization should be informed of this recall. If you have further distributed the recalled product, to the wholesale or retail level, please notify any accounts or additional locations which may have received the recalled product from you. For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

- Complete and submit the report Online: [www.fda.gov/MedWatch/report](http://s2027422842.t.eloqua.com/e/er?utm_campaign=Labetalol%20Hydrochloride%20Injection%20by%20Hospira%3A%20Recall&utm_medium=email&utm_source=Eloqua&s=2027422842&lid=43&elqTrackId=F0B8274B5FF62DF6AE221FFB9E0FE422&elq=acde387e3ac0409aad3a1ceb3f70b5ec&elqaid=2548&elqat=1)
- [Download form](http://s2027422842.t.eloqua.com/e/er?utm_campaign=Labetalol%20Hydrochloride%20Injection%20by%20Hospira%3A%20Recall&utm_medium=email&utm_source=Eloqua&s=2027422842&lid=57&elqTrackId=C48626B2D8371700E6986ACD4025713A&elq=acde387e3ac0409aad3a1ceb3f70b5ec&elqaid=2548&elqat=1) or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

<https://blog.theironslawfirm.com/author/harry-albritton>

### [Harry Albritton](https://blog.theironslawfirm.com/author/harry-albritton)

Harry H. Albritton, Jr. is a passionate attorney representing victims of negligence and malpractice, with deep roots in eastern North Carolina. A graduate of East Carolina University, he returned to practice law in Pitt County after obtaining his law degree from Ohio Northern University. Throughout his career, he has successfully handled a diverse range of cases, from minor car accidents to multi-million dollar catastrophic injuries, and has been recognized for his legal abilities by Super Lawyers and The National Trial Lawyers. When not practicing law, he prioritizes spending time with his wife and three sons, engaging in outdoor activities such as hiking, biking, and kayaking.

<https://www.linkedin.com/in/harry-albritton-b46a534/> <https://theironslawfirm.com/>

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