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  • FDA Date: 12/06/2012

    Heparin Sodium FDA Drug Safety Communication

    Important change to heparin container labels to clearly state the total drug strength

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

    FDA is notifying health care professionals, caregivers, and patients about a change to the container and carton labels for heparin products, which are blood-thinning agents that prevent the formation of blood clots.

    This label change will require manufacturers of Heparin Lock Flush Solution, USP and Heparin Sodium Injection, USP to clearly state the strength of the entire container of the medication followed by how much of the medication is in 1 milliliter (mL). These modifications will eliminate the need for health care professionals to calculate the total amount of heparin medication in a product containing more than 1 mL, thereby reducing the risk of miscalculations that may result in medication errors.

    FDA supports the United States Pharmacopeia (USP) proposal to revise the labeling section of USP monographs for Heparin Lock Flush Solution, USP and Heparin Sodium Injection, USP to clearly state the total drug strength on the label. This will ensure that labels for heparin products comply with USP's general requirements for all small-volume injectable products, which currently display the total drug content.

    Health care professionals, caregivers, and patients should be aware that that there will be a transition period before and after the official implementation date on May 1, 2013, during which both the current heparin container labels and the revised heparin container labels will be available in the marketplace. To minimize the potential for medication errors, users should consider separating the supplies of "current" and "revised" labeled heparin, and use all of the supplies of the "current" heparin before using products with the "revised" container label.

    The proposed revision to the labeling sections in the heparin monographs will require the labels to comply with the USP standards for injectable medications, specifically USP 35 -NF 30 General Chapter <1> Injections section.

    View the full FDA Drug Safety Communication on FDA.gov