FDA Communication: Important change to heparin labeling

In November 2012, the United States Pharmacopeial Convention (USP) revised its current standards for labels for heparin sodium injection solutions to help address safety concerns regarding the expression of drug strength. This label change requires 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 revised standards became official on May 1, 2013. Healthcare professionals must be vigilant during the transition period when the current heparin labels and the revised heparin labels may appear in the marketplace concurrently.

Additional Information

  • Report medication errors or side effects from the use of heparin to FDA’s MedWatch program, using the link at the bottom of this page.
  • To minimize the potential for medication errors, hospitals and pharmacies may wish to consider separating the supplies of “current” and “revised” labeled heparin and exhausting the supplies of the “current” heparin before transitioning to products with the “revised” label.
  • Always look at the label on the heparin vial being dispensed and counsel the patient or caregiver on how to administer the correct dose.

For more information on the safety announcement and background, please click here.

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