viernes, 12 de enero de 2018

FDA notifies health care professionals that Becton-Dickinson replaced problematic rubber stoppers in its syringes - Drug Information Update

The Division of Drug Information (DDI) - serving the public by providing information on human drug products and drug product regulation by FDA

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 we 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 we have not established the suitability of these syringes (with either rubber stopper) for that purpose.

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.

For more information, please visit: BD Syringes

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