Important Safety Alerts

The United States Food and Drug Administration (FDA) is expanding a safety 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 the manufacturer's 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.

The manufacturer reports that the following drugs in particular can be affected by the stoppers, but FDA does not know whether other drugs can be affected: fentanyl, rocuronium, neostigmine, morphine, midazolam, methadone, atropine, hydromorphone, cisatracurium, and remifentanyl.

The FDA recommends the hospital and pharmacy 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.
• Check supply stocks and remove drug products that were filled by pharmacies or outsourcing facilities and stored in general purpose BD syringes. These syringes are marked with the BD logo at the base of the syringe. At this time, FDA does not have information on how long drugs can be stored in these syringes before degrading. There is no information to suggest that there is a problem with potency or drug degradation when medication is administered promptly after the syringes are filled.

The FDA is continuing to investigate this issue and will provide more information when it is available.

For details, please refer to the FDA website:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm461597.htm

[Posted on 21 August 2015]

[Updated on 9 September 2015]