Drugs

FDA Drug Safety Podcast for Healthcare Professionals: FDA advises healthcare providers to visually inspect Hospira Carpuject pre-filled cartridges for overfill

Narrator: Welcome to the FDA Drug Safety Podcast for Healthcare Professionals from the Division of Drug Information. Today’s topicis an FDA Drug Safety Alert advising healthcare providers to visually inspect Hospira Carpuject pre-filled cartridges for overfill.

Kimberly Wu, a pharmacist in the Division, will provide you with additional information about this Communication.

Speaker: On May 23, 2012 FDA is alerting healthcare providers of a potential safety risk in some Carpuject pre-filled cartridges manufactured by Hospira, Inc. The pre-filled cartridges containing certain products may be overfilled by at least twice the expected amount, resulting in potential overdoses.

FDA is advising healthcare providers to follow the instructions provided with the medication and visually inspect and confirm that the Carpuject pre-filled cartridge contains the labeled fill volume before dispensing and again before administering to patients.

Pre-filled cartridges for the following Hospira Carpuject products should be visually inspected for the possibility of overfill: Heparin, Demerol, Fentanyl, Morphine, Hydromorphone, Diazepam, Lorazepam, Midazolam, Ketorolac, Labetalol, Metoprolol, Naloxone, Ondansetron, Heparin Lock Flush Solution, and Sodium Chloride.

If a Carpuject pre-filled cartridge contains a greater volume of medication than described by the label, healthcare providers should not use the Carpuject pre-filled cartridge and should return it to Hospira.

Hospira informed the FDA of the occurrence of overfilled Carpuject pre-filled cartridges containing morphine and hydromorphone following complaints received from healthcare providers.

Subsequent inspection of retained product by Hospira found additional overfilled cartridges. The manufacturing problem thought to be responsible for this overfilling has resulted in the risk for overfilled Carpuject cartridges for as many as 280 lots of 15 different Carpuject pre-filled cartridge products.

Because pharmacists and other healthcare providers can visually identify the presence of an overfilled Carpuject pre-filled cartridge, FDA is recommending that these steps be taken at this time rather than a product recall because a recall of the affected products would result in an immediate shortage. FDA is still evaluating whether additional steps are necessary.

The FDA remains vigilant in monitoring adverse event reports and is requesting pharmacists and other health care providers to be extra cautious in prescribing and dispensing all products.

Finally, FDA is asking all healthcare providers to report adverse events involving these products to the FDA Medwatch program at www.fda.gov/medwatch.

Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. Further information can be found on our website at www.fda.gov.