Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE

Hospira Announces Voluntary Nationwide Recall Of One Lot Of Labetalol Hydrochloride Injection

By Pharmaceutical Processing | May 19, 2014

Hospira will initiate a voluntary nationwide recall to the user level for one lot of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL) 20 mL Multidose Vial, NDC 0409-2267-20, Lot 36-225-DD, Expiration 12/01/2015. (NDC and lot number can be found on the right-hand side of the primary label). The recall is due to a confirmed customer report of embedded particulate within the glass vial and visible particles floating in the solution. Based upon the complaint sample analysis, there is the potential for product to come into contact with embedded particles and the particles may become dislodged into the solution. The embedded particulate was identified as stainless steel and the floating particulate as iron oxide. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. Hospira has attributed the embedded particulate to a supplier’s glass defect. As a result of this issue, Hospira is working with its supplier on implementing corrective and preventive actions.

If the particulate is administered undetected – the health implications will vary depending on the amount of particulate matter injected into the patient, the size of the particles, the patient’s underlying medical condition and heart abnormalities. Blocked administration of the drug to the patient, causing a delay in therapy is possible. However, due to the size of the particulates identified, it is more likely that particulates are able to pass through the catheter and may cause injection site reactions and local irritation in the blood vessels, tissues and organs. While extremely rare, particulate exposed to strong magnetic fields (e.g. MRI), could potentially dislodge and cause tissue damage. However, due to the particulate size identified, the probability of an adverse outcome resulting from such particulate when dislodged through a magnetic field is remote.

Labetalol Hydrochloride Injection, USP is a clear colorless solution for intravenous administration and is indicated for control of blood pressure in severe hypertension. The product is packaged in a 20 mL multidose glass vial, each vial is packaged within an individual carton, and 50 individual cartons are packaged within each shipping container. The recalled lot was distributed nationwide in the U.S. in February, 2014, to wholesalers/distributors, hospitals and clinics.

Hospira is notifying its distributors and customers by issuing a recall notification letter and will arrange for return/replacement of all recalled product. Anyone with an existing inventory should immediately stop use and quarantine any affected product. In addition, customers should inform potential users of this product in their organizations of this notification. For additional assistance, call Stericycle at 1-888-386-2076 (M-F, 8 a.m – 5 p.m. ET).

For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187. This phone number is available 24 hours a day, seven days a week. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

    Complete and submit the report Online:www.fda.gov/medwatch/report.htm
    Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.    

Related Articles Read More >

kobayashi pharmaceutical logo
Report: Japan health authorities investigate Kobayashi Pharmaceutical factory after five deaths
Disposable syringe and American currency on black background
PBMs increasingly under fire in drug-pricing battle
Johnson & Johnson logo
Timeline: Navigating Johnson & Johnson’s talc lawsuits and their stock performance impact
pharmaceutical industry. Production line machine conveyor with glass bottles ampoules at factory
5 core trends in drug recalls: An analysis of 2022 and Q1 2023
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE