Class 4 Drug Alert Prenoxad 1mg/ml Solution for Injection, Macarthys Laboratories (Aurum Pharmaceuticals Ltd/Ethypharm Group), NatPSA/2022/009/MHRA

Macarthys Laboratories (trading as Martindale Pharma, an Ethypharm Group Company), has notified the MHRA of a limited number of Prenoxad packs in a batch marketed in France with missing needles.

MDR Number: MDR 219-10/22

Company name: Macarthys Laboratories (Trading as Martindale Pharma, an Ethypharm Group Company)

[Marketing Authorisation Holder - Aurum Pharmaceuticals Ltd]

Product description:

Prenoxad 1mg/ml Solution for Injection in a pre-filled syringe, PL 12064/0125

Active Pharmaceutical Ingredient: naloxone hydrochloride

Brief description of problem:

Macarthys Laboratories (trading as Martindale Pharma, an Ethypharm Group Company), has notified the MHRA that a limited number of Prenoxad kits (also called 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 (specified above) 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 1¼ 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 below and supplementary information.

Advice to Healthcare Professionals:

Company contacts for further information:

For more information on licensed stock and resupply queries for the licensed presentation, please contact licensed@ethypharm.com; telephone number: 0800 028 7933.

For medical information queries and all other enquiries, please contact medinfo@ethypharm.com; telephone number 01277 266 600.

Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

To access the full recall:

Download documents

National Patient Safety Alert: Prenoxad 1mg/ml Solution for Injection, Macarthys Laboratories (Aurum Pharmaceuticals Ltd/Ethypharm Group), due to potential missing needles in sealed kits, NatPSA/2022/009/MHRA

Class 4 Medicines Defect Information: Macarthys Laboratories (Aurum Pharmaceuticals Ltd/Ethypharm Group), Prenoxad 1mg/ml Solution for Injection

Supplementary Information for patients - Prexonad 1mg/ml Solution for Injection