FDA is expanding its alert regarding compounded or repackaged drugs stored in Becton-Dickinson (BD) general use syringes to include certain additional syringe sizes including 1mL, 10mL, 20mL and 30mL BD syringes, and BD oral syringes. The FDA’s original alert applied to compounded or repackaged drugs that have been stored in 3 mL and 5mL BD syringes. This expansion of the alert to additional sizes of syringes is based on BD reports that an interaction with the rubber stopper in certain lots of these syringes can cause some drugs stored in these syringes to lose potency if filled and not used immediately.
BD reports that the following drugs in particular can be affected by the stoppers, but we do not know whether other drugs can be affected: fentanyl, rocuronium, neostigmine, morphine, midazolam, methadone, atropine, hydromorphone, cisatracurium, and remifentanyl. BD has created a webpage to assist customers in determining if their lots are affected.
Hospital pharmacies and staff should:
•Contact any outsourcers to determine if affected lots of BD syringes were used for compounded or repackaged products
•Not administer compounded or repackaged drugs that have been stored in any of these syringes unless there is no suitable alternative available.
FDA continues to investigate this issue and will provide more information when it is available.
FDA asks health care professionals and patients to report any adverse reactions to FDA’s MedWatch program:
•Complete and submit the report online at www.fda.gov/medwatch/report.htm
•Download and complete the form, then submit it via fax at 1-800-FDA-0178
