Macarthys Laboratories (trading as Martindale Pharma, an Ethypharm Group Company), has notified the MHRA that a limited number of Prenoxad kits (packs) in a batch marketed in France have missing needles.
Although no reports of UK marketed kits with missing needles have been received to date, the potential for kits to contain fewer than two (2) needles in all distributed batches (see page 2) cannot be excluded based on the investigation by the company. However, due to the critical need for this product, the specified batches are not being recalled.
Prenoxad kits are packed with two (2) Terumo 23 gauge 1ΒΌ inch needles, along with the pre-filled syringe containing the active ingredient (naloxone hydrochloride), and a Patient Information Leaflet.
Naloxone is a drug that reverses the effects of an opioid overdose. If no needles are present in the kit, there is a risk that patients, members of the public and/or healthcare professionals may not be able to administer life-saving doses of naloxone from these kits in an emergency. This may impede the treatment for a patient with an opioid overdose, which may result in delay to intervention and possible death.
Healthcare professionals and service providers should note the actions required before supplying Prenoxad kits.
We ask providers to contact individuals supplied with Prenoxad kits where possible and support checks to ensure kits contain two (2) needles in each kit. Support should be provided to individuals with kits who are unsure how to check their kits. See page 2 and supplementary information.
This National Patient Safety Alert contains further information and actions for providers.