FDA Expands Warning on BD Syringes

September 9, 2015
BioPharm International Editors

FDA warns that compounded or repackaged drugs stored in certain syringes made by Becton-Dickinson may lose potency because of an interaction with the rubber stopper.

FDA alerted healthcare professionals in an Aug. 19, 2015 release that compounded or repackaged drugs stored in 3-mL and 5-mL Becton-Dickinson (BD) general-use syringes might lose potency over a period of time, if not used immediately after filling because of a possible interaction with the rubber stopper in the syringe. The alert was expanded in a Sept. 8, 2015 press release to certain additional syringe sizes including 1-mL, 10-mL, 20-mL, and 30-mL BD syringes, as well as BD oral syringes. Specific lots that are affected are listed on BD’s website.

BD reports that the following drugs in particular can be affected by the stoppers: fentanyl, rocuronium, neostigmine, morphine, midazolam, methadone, atropine, hydromorphone, cisatracurium, and remifentanyl; but FDA does not know whether other drugs can be affected, noted the agency in the alert. FDA stated the agency was continuing to investigate this issue and would provide more information when it is available.

Source: FDA