HOSPIRA ANNOUNCES IMPORTANT SAFETY INFORMATION REGARDING CARPUJECT SYRINGE SYSTEM AND THE POTENTIAL FOR OVERFILL

Posted Friday, May 18, 2012

HOSPIRA ANNOUNCES IMPORTANT SAFETY INFORMATION REGARDING CARPUJECT SYRINGE SYSTEM AND THE POTENTIAL FOR OVERFILL -- Company requests healthcare professionals visually inspect and confirm the fill volume prior to administration --
LAKE FOREST, Ill., May 18, 2012 – Hospira, Inc. (NYSE: HSP) announced today that it is notifying healthcare professionals regarding the potential for overfill in the pre-filled Carpuject™ Syringe System, as some syringes may contain more medication than is stated on the label. The notice applies to Carpuject syringes and the 2mL iSecure™ presentations of midazolam and ondansetron within expiration, which includes the following 15 drugs, all of which were manufactured between June 2010 and February 2012.

  • Fentanyl Citrate
  • Heparin Sodium
  • HYDROmorphone HCl
  • Morphine Sulfate
  • Demerol™ (meperidine HCl)
  • Labetalol Hydrochloride
  • Metoprolol Tartrate
  • Diazepam
  • Ketorolac Tromethamine
  • Lorazepam
  • Midazolam
  • Naloxone Hydrochloride
  • Ondansetron
  • Sodium Chloride
  • Heparin Lock Flush Solution

Hospira has not received any reports of adverse events related to this issue to date. The company has identified the root cause to be due to a manufacturing issue in the filling equipment and has implemented corrective actions to prevent further occurrence.
At this time, although it is believed that the potential for overfill occurrence (where the syringe contains more than the intended fill volume) is low, medication overfill has been reported. If administered to patients, overfilled syringes can lead to accidental overdose, which could have significant impact to patients and result in life-threatening consequences.
HOSPIRA ANNOUNCES IMPORTANT SAFETY INFORMATION
REGARDING CARPUJECT SYRINGE SYSTEM AND THE
POTENTIAL FOR OVERFILL
PAGE 2
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Required for Healthcare Professionals
Before administering the medications contained in the pre-filled Carpuject syringes, healthcare
providers should visually inspect the fill volume in the syringe and verify that it matches the
labeled volume. For photos of the Carpuject syringe and a list of potentially impacted products
and lots, please click here.

On inspection, if an overfilled Carpuject syringe is detected, the unit should not be used. The
clinician should report the incident to Hospira as a complaint, including specific product
information and lot number, and return the product to Hospira for evaluation.
For the recently recalled lots of Morphine Sulfate Injection, USP, 4 mg/mL, or Hydromorphone
Hydrochloride Injection 1 mg/1mL, healthcare professionals are reminded to follow the
instructions in the relevant recall notices.

For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187 (24
hours a day, seven days a week) or email Medcom@hospira.com. To report product
complaints, such as an overfilled Carpuject or adverse events, call 1-800-441-4100 or email
productcomplaintspp@hospira.com.

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.

  • Online: www.fda.gov/medwatch/report.htm
  • Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
  • Fax: 1-800-FDA-0178

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