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FDA Advises Checking Prefilled Syringes for Overfilling


May 23, 2012 — The US Food and Drug Administration (FDA) today issued an advisory warning healthcare providers to visually inspect Hospira Carpuject prefilled cartridges for overfill.
About 46 million units are included in the 280 lots involved in the warning, according to company spokesperson Tareta Adams. However, Adams noted that clinicians should, as part of using any prefilled syringe, visually inspect it before using. In addition, she told Medscape Medical News that much of the supply in question that is currently circulating has been used up. In addition, according to the FDA, the firm's investigation found that the number of overfilled Carpuject prefilled cartridges appears to be low.
The FDA advisory covers 15 types of medications supplied in the form of a Carpuject prefilled syringe. Products include meperidine, diazepam, fentanyl, heparin, hydromorphone, ketorolac, labetalol, lorazepam, metoprolol, midazolam, morphine, naloxone, ondansetron, and sodium chloride. A complete list of products and lot numbers is available on the FDA's Web site.
The FDA recommends that clinicians "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."
"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 listed above would result in an immediate shortage," the FDA states. "FDA is still evaluating whether additional steps are necessary."
Today's warning comes in the wake of an actual recall of a lot of Carpuject morphine syringes last month.
The product should be returned to the manufacturer if the syringe cartridge contains a greater volume of medication than described by the label, the company states.
Healthcare professionals and patients are encouraged to report overfilled Carpuject prefilled cartridges to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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