FDA MedWatch - Compounded or Repackaged Drugs Stored in Becton-Dickinson Syringes: FDA Expands Warning

Compounded or Repackaged Drugs Stored in Becton-Dickinson Syringes: FDA Expands Warning

Alert now includes 1 mL, 10 mL, 20 mL, and 30 mL BD syringes, and BD oral syringes

AUDIENCE: Pharmacy, Nursing, Risk Manager, Compounding

ISSUE: 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. See the FDA Alert for links to the BD webpage to determine which specific lots are affected. FDA continues to investigate this issue and will provide more information when it is available.

BACKGROUND: 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 include 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 FDA does not know whether other drugs can be affected: fentanyl, rocuronium, neostigmine, morphine, midazolam, methadone, atropine, hydromorphone, cisatracurium, and remifentanyl.

RECOMMENDATION: 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Read the MedWatch Safety Alert, including a link to the FDA Alert at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm461597.htm