The FDA issued a safety alert recently for repackaged drugs sold in syringes manufactured by Becton-Dickinson. Originally, the warning was only for the 3- and 5-mL syringes, but this month the warning has been expanded to include oral syringes and 1-, 10-, 20-, and 30-mL syringes as well.
“Unless there is no suitable alternative available,” the Becton-Dickinson syringes should not be administered to hospital patients, the FDA said. When the drug interacts with the rubber stopper in the syringe, it may lose potency over time. If used promptly, though, the drugs should not have any potency issues.
Becton-Dickinson admitted that certain drugs can be affected by the rubber stoppers. These drugs include fentanyl, rocuronium, neostigmine, morphine, midazolam, methadone, atropine, hydromorphone, cisatracurium, and remifentanyl. The manufacturer is unsure whether other drugs may be affected too.
Syringes that are marketed as pre-filled are unaffected by this new safety alert, since the FDA has approved the drugs, determining that they will remain potent until the expiration date. Other manufacturers’ pre-packaged syringes, however, may also have a chemical reaction with rubber stoppers. The FDA is looking further into this issue.
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