National Patient Safety Alert: Class 4 Medicines Defect Information: 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
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.
This alert is for action by: primary and secondary care, specifically those involved in outreach services.
This is a safety critical and straightforward National Patient Safety Alert. Implementation should be coordinated by an executive leader (or equivalent role in organisations without executive boards) supported by Chief Pharmacists, Chief Nurse and Head of Procurement/Supplies or equivalent roles, as well as leaders in general practice and community pharmacy, in collaboration with Directors of Public Health/Commissioners and providers of drug treatment and prevention services and other relevant service.
National Patient Safety Alert Reference Number
NatPSA/2022/009/MHRA
PL Number
Prenoxad 1mg/ml Solution for Injection in a pre-filled syringe, PL 12064/0125
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
| Batch/Lot Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 0116917 | 02/2023 | 1 kit | 27 March 2020 |
| 0119973 | 02/2023 | 1 kit | 09 April 2020 |
| 0120140 | 02/2023 | 1 kit | 09 April 2020 |
| 0125553 | 04/2023 | 1 kit | 13 May 2020 |
| 0125555 | 04/2023 | 1 kit | 24 July 2020 |
| 0125724 | 04/2023 | 1 kit | 09 June 2020 |
| 0126941 | 05/2023 | 1 kit | 03 July 2020 |
| 0126943 | 06/2023 | 1 kit | 16 July 2020 |
| 0130203 | 08/2023 | 1 kit | 06 October 2020 |
| 0130732 | 08/2023 | 1 kit | 16 October 2020 |
| 0130843 | 09/2023 | 1 kit | 15 October 2020 |
| 0134251 | 01/2024 | 1 kit | 26 February 2021 |
| 0136031 | 04/2024 | 1 kit | 01 July 2021 |
| 0136536 | 05/2024 | 1 kit | 03 August 2021 |
| 0136551 | 05/2024 | 1 kit | 03 August 2021 |
| 0137656 | 09/2024 | 1 kit | 24 October 2021 |
| 0137768 | 10/2024 | 1 kit | 07 December 2021 |
| 0138525 | 11/2024 | 1 kit | 26 January 2022 |
| 0138904 | 01/2025 | 1 kit | 14 March 2022 |
| 0139907 | 04/2025 | 1 kit | 17 May 2022 |
| 0140236 | 04/2025 | 1 kit | 10 June 2022 |
| 0141035 | 06/2025 | 1 kit | 22 September 2022 |
| 0141812 | 07/2025 | 1 kit | 21 October 2022 |
| 0141969 | 08/2025 | 1 kit | 11 October 2022 |
Active Pharmaceutical Ingredient: naloxone hydrochloride
Explanation of identified safety issue
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.
Actions required
Advice for all healthcare professionals and service providers, including community pharmacies, emergency services, and prisons
Enact an action plan to implement actions in the MHRA Class 4 Medicines Defect Information: Caution in Use by 17 November 2022. This includes:
- Check all Prenoxad kits in place at your organisation against the batches specified in this alert.
- Visually inspect the front of the kit (with the Lot number and 2D matrix facing you) against a light source to confirm two (2) needle packets are present in the kit (see images in the MHRA Class 4 Medicines Defect Information).
- If needles cannot be clearly seen by the visual inspection of the kit(s), the kit(s) can be physically opened to confirm the presence of two (2) needles inside the kit(s) (see images in the MHRA Class 4 Medicines Defect Information). The kit(s) can be closed after visual inspection. As the tamper evident seal (TES) will be broken as part of the physical inspection process, it is recommended that kit(s) are only opened at the point of dispensing or supplying to a patient/member of the public, so that they are aware of the reason for breaking the seal. Note that the clear plastic cap at the end of the pre-filled syringe must remain intact in order to maintain sterility of the medicinal product (see images in the MHRA Class 4 Medicines Defect Information).
- Where there are kit(s) in your stock without two (2) needles, quarantine these immediately and contact Ethypharm to arrange for replacement kit(s). Similarly, where there are concerns around visual or physical inspection of the kit(s), contact Ethypharm for further advice or to arrange replacement kit(s).
- Report any defective kits via the MHRA Yellow Card scheme, including if kits were without two (2) needles in the kit. Include the batch number in this report.
- If urgent use of Prenoxad is required in an emergency and needles are missing from the kit, Terumo 23 gauge 1¼ inch needles or reasonable alternative needles should be used for intramuscular administration.
- If patients or members of the public report a Prenoxad kit without two (2) needles in the kit, arrange for a replacement and visually check for the presence of two (2) needles before supplying this.
- Where healthcare professionals, service providers and local teams (including those involved in needle and syringe programmes) are able to make contact with patients and members of the public who have been supplied with Prenoxad, they should inform them to check their kits to ensure they contain two (2) needles in each pack. Support should be provided to individuals with kits who are unsure how to check their kits. The action to contact all holders of kits will depend on the local procedures for record keeping, but efforts should be made to inform all likely holders of Prenoxad. Please see Supplementary Information for the individuals, patients and/or members of the public provided in the link below.
- If patients, individuals or members of the public report a Prenoxad kit without two (2) needles in the kit, arrange for a replacement and visually check for the presence of two needles before supplying the new Prenoxad kit, as per the instructions in the appendices.
- Please see the Summary of Product Characteristics for additional information on the use and safety of this product.
Advice for patients and members of the public, including peers, friends, family, carers
Check to see if you have any kits of Prenoxad Injection in your possession or at home. It is possible that some Prenoxad kits contain fewer than two (2) needles in each kit. A needle is needed to administer the medicine (naloxone) from the pre-filled syringe. If a needle is not available, this means the medicine cannot be used to reverse opioid overdose in an emergency.
Anyone with a Prenoxad kit is asked to visually check the contents by holding it against a light source to confirm the presence of two (2) needle packets. See images in Appendix 1 of the MHRA Class 4 Medicines Defect Information or Supplementary Information document below for reference.
Alternatively, you could open your Prenoxad Injection kit to confirm that there are two (2) needles in each kit. See images in Appendix 2 of the MHRA Class 4 Medicines Defect Information or Supplementary Information document below for reference. If you open the kit, do not touch the pre-filled syringe (the tube with liquid in). The clear plastic cap at the end of the pre-filled syringe must be intact so that the injection remains sterile. See images in Appendix 3 of the MHRA Class 4 Medicines Defect Information or Supplementary Information document below for reference. The kits can be closed after visual inspection. Always click the kit closed after it is opened to ensure the contents stay secure.
If you are unclear on how to visually check or physically open a Prenoxad kit, you can take it back to the healthcare professional or service provider who initially supplied this medicine to you and request assistance in checking the kit. This may be the local drug treatment service, a community pharmacy involved in support programmes, needle and syringe programmes, peer support groups, or drugs outreach workers.
If you see that your kit does not contain two needles, you must take it back to the provider who gave you the kit, or a community pharmacy involved in needle and syringe programmes, or a local substance misuse team or service provider, for a replacement.
As per the advice stated in the Patient Information Leaflet, Prenoxad Injection should be carried by people at risk of an opioid overdose, therefore it is important that you have a replacement provided to you when you return any affected kits.
There are no concerns about the medicine in these kits. If you, or somebody you observe, has taken an opioid and are experiencing the symptoms of opioid overdose, please seek medical assistance or visit the nearest accident and emergency centre. If you have nasal naloxone or injectable naloxone (with a needle) available, administer it according to the instructions in the kit. Symptoms of overdose can include the following:
- pinpoint pupils
- loss of consciousness (i.e. the person cannot be woken)
- respiratory depression/breathing slows or stops
- extremely pale face that may feel clammy to the touch
- bluish purple tinge to lips or fingernails
- no response to noise/cannot be awakened, unable to speak
- vomiting or making gurgling noises
If someone has symptoms of an opioid overdose and is not breathing, call 999 and ask for an ambulance immediately.
Please see Patient Information Leaflet for further information.
Further information
Please see Supplementary Information for the individuals, patients and/or members of the public.
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.
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