January 12, 2018
Audience: Pharmacy, Health Professionals, Risk Manager
ISSUE: Becton-Dickinson (BD) informed FDA that it is no longer using the rubber stopper material associated with loss of drug potency in its general use syringes, and BD has instead returned to a rubber stopper it used previously in the syringes.
In 2015, FDA initially alerted health care professionals not to administer compounded and repackaged drugs stored in certain sizes of general use BD syringes, based on reports of an interaction with the rubber stopper that caused some drugs stored in these syringes to lose potency when not used immediately. As stated previously, the general use BD syringes are cleared for immediate use in fluid aspiration and injection, but not for use as a closed container storage system for drug products, and FDA has not established the suitability of these syringes (with either rubber stopper) for that purpose.
BACKGROUND: The FDA’s original alert in August 2015 applied to compounded or repackaged drugs that have been stored in 3 mL and 5mL BD syringes; FDA expanded its alert in September 2015 to include certain additional syringe sizes including 1mL, 10mL, 20mL and 30mL BD syringes, and BD oral syringes.
RECOMMENDATION: Health care professionals may contact BD at (201) 847-6800 for more information and for confirmation that the specific lots of syringes used by a facility contain the new stoppers.
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
[01/12/2018 – Alert – FDA]