In a safety alert issued August 18th, the FDA stated that compounded or repackaged drugs that have been stored in 3- and 5-mL syringes manufactured by Becton-Dickinson should not be administered to patients "unless there is no suitable alternative available." Preliminary information indicated 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.
On September 8, the FDA expanded this alert to include additional syringe sizes, including 1-, 10-, 20- and 30-mL Becton-Dickinson syringes, as well as the company's oral syringes.
"This expansion of the alert to additional sizes of syringes is based on Becton-Dickinson reports that an interaction with the rubber stopper in certain lots of these syringes can cause some of the drugs stored in these syringes to lose potency if filled and not used immediately," the FDA said.
According to Becton-Dickinson, the following drugs in particular can be affected by the stoppers, although they do not know whether other drugs can be affected: fentanyl, rocuronium, neostigmine, morphine, midazolam, methadone, atropine, hydromorphone, cisatracurium, and remifentanil.
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.
The FDA is continuing to investigate this issue and will provide more information when it is available.