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|
|5% Dextrose Injection, USP; 1000 mL container||0409-7922-09||33-094-JT||1SEP2015|
|5% Dextrose and 0.45% Sodium Chloride Injection, USP; 1000 mL container||0409-7926-09||33-095-JT||1SEP2015|
|Lactated Ringer’s and 5% Dextrose Injection, USP; 1000 mL container||0409-7929-09||34-134-JT||1OCT2015|
|5% Dextrose and 0.9% Sodium Chloride Injection, USP; 1000 mL container||0409-7941-09||32-104-JT||1AUG2015|
|Lactated Ringer’s Injection, USP; 1000 mL container||0409-7953-09||32-099-JT||1AUG2015|
|Normosol®-R Multiple Electrolytes Injection Type 1, USP; 1000 mL container||0409-7967-09||32-081-JT||1AUG2015|
|0.9% Sodium Chloride Injection, USP; 1000 mL container||0409-7983-09||32-044-JT||1AUG2015|
|0.45% Sodium Chloride Injection, USP; 1000 mL container||0409-7985-09||33-027-JT||1SEP2015|
|Sterile Water for Injection, USP; 1000 mL container||
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 firstname.lastname@example.org (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.