Cl Il Hospira LifeCare PCA Label Utility

Company: Hospira, Inc
Date of Enforcement Report 8/13/2008
Class:ll

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, Recall # Z-1181-2008

REASON
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.

RECALLING FIRM/MANUFACTURER
Hospira, Inc., Lake Forest, IL, by letters dated January 3, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
127 CDs

DISTRIBUTION
Nationwide and Canada

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