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FDA Expands Warning About Becton-Dickinson Syringes

Rubber stopper in certain lots and sizes may lead to decreased drug potency

Compounded or repackaged drugs stored in some lots of Becton-Dickinson (BD) general-use syringes could interact with the syringes’ rubber stoppers and lose potency if not used immediately, the FDA and BD are warning.

The FDA  has expanded its original alert, which applied to compounded or repackaged drugs stored in 3-mL and 5-mL BD syringes, to include 1-mL, 10-mL, 20-mL, and 30-mL BD syringes and BD oral syringes.

The FDA does not know how long drugs can be stored in the 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.

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 use as closed-container storage.

BD says the following drugs in particular can be affected by the stoppers: fentanyl, rocuronium, neostigmine, morphine, midazolam, methadone, atropine, hydromorphone, cisatracurium, and remifentanyl. However, the FDA does not know whether other drugs can be affected.

BD has created a webpage (http://www1.bd.com/alerts%2Dnotices/)  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 no suitable alternative is available.

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

The FDA is continuing to investigate this issue.

Source: FDA; September 8, 2015.

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