Important Safety Information Regarding Carpuject Syringe System? Potential Overfill

Posted Friday, May 18, 2012

Dear Healthcare Professional,

Hospira is issuing this Important Safety Information letter to alert Healthcare Professionals to the
potential overfill of volume amounts in the pre-filled Carpuject syringe system. This also includes
the 2 mL iSecure presentations of midazolam and ondansetron. Hospira has received reports of
Carpuject syringes containing more than the labeled fill volume of medication than is stated on
the label. See attached for list of affected products and lots.

Healthcare professionals should visually inspect the fill volume in the pre-filled Carpuject syringe
and verify that it matches the labeled volume to ensure patients receive the prescribed amount of
medication. See attached photos for examples of correctly filled cartridge volumes. Overfilled
syringes can lead to accidental overdose which could have significant impact on patients resulting
in life-threatening consequences.

The root cause has been identified as a manufacturing issue in the filling equipment and
corrective actions have been implemented to prevent further occurrence. To date, no adverse
events have been reported. At this time, although it is believed that the potential for overfill
occurrence (where the syringe contains more than the labeled fill volume) is low, medication
overfill has been reported.

Directions for Healthcare Providers
Before administration visually inspect and confirm the Carpuject syringe contains the
labeled fill volume. On inspection, if an overfilled Carpuject syringe is detected, the unit should
not be used. The clinician should report the incident to Hospira, Inc. and include specific product
information and lot number. The Carpuject syringe should be returned to Hospira for evaluation.
For medical inquires, please contact Hospira Medical Communications at 1-800-615-0187 (24
hours a day, seven days a week) or e-mail To report product
complaints, such as an overfilled Carpuject or adverse events call 1-800-441-4100 or e-mail

Adverse reactions or quality problems experienced with the use of this product may be reported
to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178

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