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

Hospira, Inc. announced recently 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.

Action 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.

About Hospira
Hospira, Inc. is the world's leading provider of injectable drugs and infusion technologies. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill., and has approximately 15,000 employees. For more information, visit www.hospira.com.

SOURCE: Hospira One 2 One