FDA warns customers not to use BD 3ml and 5ml syringes

Published: 20-Aug-2015

Drugs stored in these syringes may lose potency due to possible interaction with the rubber stopper

The US FDA is alerting healthcare professionals not to administer to patients compounded or repackaged drugs that have been stored in 3ml and 5ml syringes manufactured by Becton-Dickinson (BD) unless there is no suitable alternative available.

Preliminary information indicates that drugs stored in these syringes may lose potency over a period of time due to a possible interaction with the rubber stopper in the syringe, the regulator said.

BD’s 10ml, 20ml and 30ml syringes may also contain the same rubber stopper. The company is warning customers not to use these syringes as a closed container system for compounded and repackaged drugs.

The FDA has cleared these syringes as medical devices for general purpose fluid aspiration and injection only. They were not cleared for use as a closed container storage system for drug products, and their suitability for that purpose has not been established.

This issue may extend to other general use syringes made by other manufacturers that were not cleared for the purpose of closed-container storage usage, the FDA warned.

The FDA said it has received several reports of compounded and repackaged drugs, such as fentanyl, morphine, methadone and atropine, losing potency when stored in BD 3ml and 5ml general purpose syringes. It is possible that this chemical reaction may affect other compounded and repackaged drugs stored in syringes not FDA cleared for closed-container storage.

These syringes are marked with the BD logo at the base of the syringe.

Currently the 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.

On 30 July, the Institute for Safe Medication Practices (ISMP) issued a Special Alert regarding this problem.

The FDA is continuing to investigate this issue.

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