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Published on 7 December 2012

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Change to the container and carton labels for heparin

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The US Food and Drug Administration (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 millilitre (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 1ml, thereby reducing the risk of miscalculations that may result in medication errors.
FDA supports the United States Pharmacopeia (USP) proposal to revise the labelling 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.


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