Company: Hospira, Inc
Date of Enforcement Report 8/13/2008
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, Recall # Z-1181-2008
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.
Hospira, Inc., Lake Forest, IL, by letters dated January 3, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Canada