UPDATE [1/12/2018] 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.

FDA encourages health care professionals and patients to report adverse events or quality problems experienced with the use of any medical product to FDA’s MedWatch Adverse Event Reporting program:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.

FDA expands warning on Becton-Dickinson (BD) syringes being used to store compounded or repackaged drugs

[9-8-2015] 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.  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 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 we do not know whether other drugs can be affected: fentanyl, rocuronium, neostigmine, morphine, midazolam, methadone, atropine, hydromorphone, cisatracurium, and remifentanyl. BD has created a webpage to assist customers in determining if their lots are affected.

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.

FDA continues to investigate this issue and will provide more information when it is available. 
FDA asks health care professionals and patients to report any adverse reactions to FDA’s MedWatch program:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm
• Download and complete the form, then submit it via fax at 1-800-FDA-0178

BD issued letters to their customers on July 31, 2015 and September 1, 2015, and provides an Alternate Stopper Quick Reference Guide on their webpage.  The Institute for Safe Medication Practices (ISMP) issued statements regarding this issue in July and August 2015. 

FDA warns health care professionals not to use compounded or repackaged drugs stored in Becton-Dickinson (BD) 3 milliliter (ml) and 5 ml syringes unless there is no suitable alternative available

[8-19-2015] FDA is alerting health care professionals not to administer to patients compounded or repackaged drugs that have been stored in 3 milliliter (ml) 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. 

If you have been using products packaged in these syringes, be aware that using a substitute product may require a dosage adjustment in case the patient has been receiving a subpotent product, or adverse consequences could occur.

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

FDA has cleared these syringes as medical devices for general purpose fluid aspiration and injection only.  These syringes were not cleared for use as a closed container storage system for drug products, and the suitability of these syringes 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.

FDA 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.

Hospital and pharmacy staff should check supply stocks and remove drug products that were filled by pharmacies or outsourcing facilities and stored in general purpose BD 3ml and 5ml 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.

This warning does not extend to products approved by FDA for marketing as pre-filled syringes, because as part of the approval process, FDA has determined that these products have been shown to maintain stability in the syringe container through the expiration date on the product.

On July 30, 2015, the Institute for Safe Medication Practices (ISMP) issued a Special Alert regarding this problem.  See //www.ismp.org/newsletters/acutecare/articles/loss-of-drug-potency.aspx

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

FDA asks health care professionals and patients to report any adverse reactions to the FDA’s MedWatch program:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm
• Download and complete the form, then submit it via fax at 1-800-FDA-0178

The BD logo is marked on the base on the syringe, and may be covered by a label on the product.