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 Certain Lots of Several Lifecare Products

By Pharmaceutical Processing | October 15, 2014

Hospira has announced the voluntary recall of certain lots of several products in its LifeCare™ line of flexible intravenous solutions due to the potential for leakage. The issue, which Hospira notified customers about in a Dear Health Care Provider letter issued earlier this year, was identified during re-inspection of a manufactured product lot in which a single puncture mark was identified going through the overwrap and primary container.

The puncture in the primary container may result in leakage that is difficult to detect. Leakage may result in an open system, which has the potential for contamination, compromised sterility, drug waste, spillage, inadequate or inconsistent solution/medication dosing, and/or delay in therapy, all of which may require medical intervention and should be reported to Hospira and/or the U.S. Food and Drug Administration (FDA). Hazardous topical exposure may occur if a hazardous drug is added to the flexible container. Hospira’s product insert packaged with LifeCare flexible intravenous containers recommends providers do not administer unless solution is clear and the container is undamaged.

The root cause is attributed to a defect in a conveyance system, and corrective actions have since been implemented to prevent a reoccurrence. To date there have been no reports of adverse events associated with this issue for the impacted lots. The manufacturing issue that caused this incident has been addressed. Hospira recommends impacted customers check with their local Hospira representative or with Hospira Customer Care regarding replacement product.

The affected lots (see table below) were originally distributed by Hospira to direct accounts from September 2013 through October 2014.

 

Product NDC Number Lot Expiration Date
Normosol®-R pH 7.4 Multiple Electrolytes Injection Type 1, USP; 1000 mL container 0409-7670-09 32-082-JT 1AUG2015
Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP; 1000 mL container 0409-7902-09 34-017-JT 1OCT2015
35-100-JT 1NOV2015
5% Dextrose Injection, USP; 1000 mL container 0409-7922-09 33-094-JT 1SEP2015
35-028-JT 1NOV2015
5% Dextrose and 0.45% Sodium Chloride Injection, USP; 1000 mL container 0409-7926-09 33-095-JT 1SEP2015
36-030-JT 1DEC2015
Lactated Ringer’s and 5% Dextrose Injection, USP; 1000 mL container 0409-7929-09 34-134-JT 1OCT2015
34-166-JT 1OCT2015
5% Dextrose and 0.9% Sodium Chloride Injection, USP; 1000 mL container 0409-7941-09 32-104-JT 1AUG2015
34-136-JT 1OCT2015
36-092-JT 1DEC2015
Lactated Ringer’s Injection, USP; 1000 mL container 0409-7953-09 32-099-JT 1AUG2015
32-103-JT 1AUG2015
34-070-JT 1OCT2015
34-086-JT 1OCT2015
34-165-JT 1OCT2015
35-085-JT 1NOV2015
35-115-JT 1NOV2015
35-121-JT 1NOV2015
36-057-JT 1DEC2015
Normosol®-R Multiple Electrolytes  Injection Type 1, USP; 1000 mL container 0409-7967-09 32-081-JT 1AUG2015
34-115-JT 1OCT2015
0.9% Sodium Chloride Injection, USP; 1000 mL container 0409-7983-09 32-044-JT 1AUG2015
32-072-JT 1AUG2015
32-102-JT 1AUG2015
33-028-JT 1SEP2015
33-046-JT 1SEP2015
33-049-JT 1SEP2015
33-061-JT 1SEP2015
33-085-JT 1SEP2015
33-096-JT 1SEP2015
33-101-JT 1SEP2015
33-102-JT 1SEP2015
34-016-JT 1OCT2015
34-085-JT 1OCT2015
34-122-JT 1OCT2015
34-123-JT 1OCT2015
35-026-JT 1NOV2015
35-030-JT 1NOV2015
35-067-JT 1NOV2015
36-002-JT 1DEC2015
36-029-JT 1DEC2015
36-049-JT 1DEC2015
36-058-JT 1DEC2015
36-103-JT 1DEC2015
37-013-JT

1JAN2016

0.45% Sodium Chloride Injection, USP; 1000 mL container 0409-7985-09 33-027-JT 1SEP2015
33-045-JT 1SEP2015
33-097-JT 1SEP2015
35-068-JT 1NOV2015
36-112-JT 1DEC2015
37-012-JT 1JAN2016
Sterile Water for Injection, USP; 1000 mL container

0409-7990-09

36-084-JT 1DEC2015

Anyone with an existing inventory of the recalled lots should stop use and distribution and quarantine the product immediately. This recall is being carried out to the medical facility/retail level (both human and veterinary). Please notify all users in your facility. If you have further distributed the recalled product please notify any accounts or additional locations which may have received the recalled product from you and instruct them if they have redistributed the product to notify their accounts, locations or facilities to the medical facility/retail level. In addition, customers should inform potential users of these products in their organizations of this notification. Hospira will be notifying its direct customers via a recall letter and will arrange for impacted product to be returned to Stericycle. For additional assistance, call Stericycle at 1-844-861-6221 between the hours of 8am to 5pm ET, Monday through Friday.

For clinical inquiries, please contact Hospira using the information provided below.

 

Hospira Contact Contact Information Areas of Support
Hospira Global Complaint Management 1-800-441-4100 (M-F, 8am-5pm CT) (ProductComplaintsPP@hospira.com) To report adverse events or product complaints
Hospira Medical Communications 1-800-615-0187 or medcom@hospira.com (Available 24 hours a day/7 days per week) Medical inquiries

 

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