Skip to main content

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.

Comments

Post a Comment

Popular posts from this blog

Contact Precautions May Have Unintended Consequences

Contact precautions, including gloves, gowns, and isolated rooms, have helped stem the transmission of hospital pathogens but have also had some negative consequences, according to findings from a new study. Healthcare worker (HCWs) visited patients on contact precautions less frequently than other patients and spent less time with those patients when they did visit, report Daniel J. Morgan, MD, from the University of Maryland School of Medicine and the Veterans Affairs (VA) Maryland Health Care System, Baltimore, and colleagues. Moreover, patients on contact precautions also received fewer outside visitors. "Less contact with HCWs suggests that other unintended consequences of contact precautions still exist," Dr. Morgan and coauthors write. "The resulting decrease in HCW contact may lead to increased adverse events and a lower quality of patient care due to less consistent patient monitoring and poorer adherence to standard adverse event prevention methods (such...
Post a Comment
Read more

FDA Decision Delayed for Truvada in HIV PrEP

June 11, 2012 — The US Food and Drug Administration (FDA) has delayed its decision on allowing the use of tenofovir disoproxil fumarate/emtricitabine ( Truvada , Gilead) as preexposure prophylaxis (PrEP) so that the proposed risk evaluation and mitigation strategy (REMS) can be reviewed. In early May, the FDA's Antiviral Drugs Advisory Committee  strongly backed  approval of the first-ever drug for the prevention of sexually acquired HIV-1 infection. However, concerns by the panel at the time included that people may neglect condom use if they feel they are protected by PrEP. Panelists were also concerned that uninfected people taking PrEP who become infected with HIV may not switch to a 3-drug regimen as recommended. According to the company, the FDA has postponed the target date to September 14 so it can review Gilead's REMS plan to help ensure that patients will not misuse the drug. The committee's recommendation for supplemental approval of tenofovir/emtricit...
Post a Comment
Read more

Antidepressants Linked to Higher Diabetes Risk in Kids

Pediatric patients who use antidepressants may have an elevated risk for type 2 diabetes, the authors of a new study report. In a retrospective cohort study of more than 119,000 youths 5 to 20 years of age, the risk for incident type 2 diabetes was nearly twice as high among current users of certain types of antidepressants as among former users, Mehmet Burcu, PhD, and colleagues report in an article  published online October 16 in  JAMA Pediatrics . The risk intensified with increasing duration of use, greater cumulative doses, and higher daily doses of these antidepressants. The findings point to a growing need for closer monitoring of these products, including greater balancing of risks and benefits, in the pediatric population, the authors caution. They undertook the study because, despite growing evidence of an association between antidepressant use and an increased risk for type 2 diabetes in adults, similar research in pediatric patients was scarce. "To our know...
Post a Comment
Read more