Other safety alerts
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| The United Kingdom: National Patient Safety Alert: Class 4 Medicines Defect Information: Macarthys Laboratories, Prenoxad 1mg/ml Solution for Injection, due to potential missing needles in sealed kits |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Macarthys Laboratories (trading as Martindale Pharma, an Ethypharm Group Company) has notified MHRA that a limited number of Prenoxad (naloxone) 1mg/ml Solution for Injection in a pre-filled syringe kits in a batch marketed in France have missing needles.
Although no reports of United Kingdom marketed kits with missing needles have been received to date, the potential for kits to contain fewer than two needles in all distributed batches 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. For details of the affected batch numbers, please refer to the website in MHRA.
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. MHRA asks providers to contact individuals supplied with Prenoxad kits where possible and support checks to ensure kits contain two needles in each kit. Support should be provided to individuals with kits who are unsure how to check their kits.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/national-patient-safety-alert-class-4-medicines-defect-information-prenoxad-1mg-slash-ml-solution-for-injection-macarthys-laboratories-aurum-pharmaceuticals-ltd-slash-ethypharm-group-due-to-potential-missing-needles-in-sealed-kits
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Nov 11, 2022
Issued at HKT 15:00
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