Date Initiated by Firm |
January 03, 2008 |
Date Posted |
August 06, 2008 |
Recall Status1 |
Terminated 3 on March 09, 2010 |
Recall Number |
Z-1181-2008 |
Recall Event ID |
46846 |
Product Classification |
pharmacy compounding software - Product Code MEA
|
Product |
Hospira LifeCare PCA Label Utility, Version 1.0 CD. The installation/user guide is entitled "LifeCare PCA Barcode Label Utility Program." This software program is designed to allow entry of each drug concentration into a formulation library on a pharmacy computer for standardized printing of barcode labels for compounded drug product vials. |
Code Information |
Version 1.0, all CDs |
Recalling Firm/ Manufacturer |
Hospira Inc. 275 N Field Dr Lake Forest IL 60045-2579
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For Additional Information Contact |
Mr. Robert DeRyke 224-212-2000
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Manufacturer Reason for Recall |
Incorrect dosage labels created: Customers have experienced independent changes in drug concentration (mg/mL to mcg/mL and vice versa) and expiration dates, and the addition of trailing zeros to the barcodes.
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FDA Determined Cause 2 |
Software design |
Action |
Hospira sent letters dated 1/3/08 to the immediate recipients of the product via FedEx overnight letter on the same date. The letters informed the accounts of the reports of independent changes in drug concentration while editing a saved formulation using the Hospira LifeCare PCA Label Utility Software CD that was provided to some customers in a Hospira MedNet Drug Library Creation Team Introductory Kit-LifeCare PCA kit. The accounts were requested to remove the utility from any PC in their facility on which it is currently installed, destroy the CD and sign and return the enclosed removal verification form verifying that they have removed the software from their system. The letter listed commercially available software packages that the account could validate and implement in their facility. Any questions concerning the utility software withdrawal were directed to Hospira at 1-800-241-4002, option 4, then option 1. |
Quantity in Commerce |
127 CDs |
Distribution |
Nationwide Distribution and Canada |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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