FDA Class I recall: 30 mL multiple-dose adrenaline vials for particulates

The FDA lists a Class I recall, dated 16 September and ongoing, of adrenaline (epinephrine) injection 1 mg/mL in 30 mL multiple-dose vials from American Regent. The reasons given are particulate matter — identified as nylon, cellulose, acrylic, polyethylene and glass — and broken or leaking vials, with lack of assurance of sterility.

Class I is the FDA's most serious category, used where there is a reasonable probability of serious harm. The recall is specific to this product and presentation; it does not concern adrenaline ampoules, prefilled syringes or auto-injectors in general. Whether this product is distributed in India is not established here.

For departments that stock multiple-dose vials for infusions, pharmacy should check lot numbers against the recall notice. Inspect any vial for visible particles or damage before drawing up, and use an in-line filter where your protocol calls for one.

• Ask pharmacy to check stock of American Regent 30 mL adrenaline vials against the recall.
• The recall covers this multiple-dose vial only, not adrenaline ampoules or auto-injectors.
• Inspect any vial for particles, cracks or leaks before drawing up.
• Report suspected contaminated product through your pharmacovigilance route.

Why it matters

Adrenaline infusions run through central lines in the sickest patients, where particulates and non-sterile product cause the most harm.

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