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| The United Kingdom: Class 2 Medicines Recall: Mercury Pharmaceuticals Ltd, Paliperidone Mercury Pharma prolonged-release suspension for injection in pre-filled syringes (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Mercury Pharmaceuticals Ltd is recalling remaining stock of paliperidone pre-filled syringes as a precautionary measure due to Good Manufacturing Practice (GMP) deficiencies cited during a recent inspection at the finished product manufacturing site. Mercury Pharmaceuticals Ltd has confirmed that due to the ongoing remedial actions at the finished product manufacturing site, there may be delays in the manufacture of future batches. For details of the affected batch numbers, please refer to the MHRA website.
Advice for Healthcare Professionals:
Stop supplying the above batches immediately. Quarantine all stock and return it to your supplier using your supplier’s approved process. Where appropriate, healthcare professionals involved in dispensing practices (pharmacy teams, homecare teams etc), should contact patients to advise them to contact their prescriber for a review to ensure that an alternative product is available, without delaying their treatment.
Where Paliperidone Mercury Pharma prolonged-release injections are unavailable, clinicians should ensure continuity of treatment and consider appropriate alternative licensed treatment options. These may include an alternative paliperidone palmitate product, another long-acting injectable antipsychotic, or, where clinically appropriate, an oral antipsychotic (including oral paliperidone or risperidone), in line with local formularies, NICE guidance, and individual patient needs. For some patients, oral treatment may be considered as a temporary bridging option until long-acting injectable therapy can be resumed. Switching between treatments should be planned to avoid missed doses and minimise the risk of relapse, with appropriate clinical monitoring for efficacy and tolerability, particularly during the initial period following a change in treatment.
No specific safety concerns have been identified with the affected batches, and a review of the company safety database has not identified any increase in adverse events associated with this issue.
Advice for Healthcare Professionals to Provide to Patients:
This recall is precautionary and relates to manufacturing standards rather than a confirmed problem with the medicine itself. Patients are advised to contact their prescriber as soon as possible to arrange treatment without interruption. Patients should continue to take the medication until they have arranged alternative treatment.
Mercury Pharmaceuticals Ltd has not identified any adverse events related to this issue. A review of the company’s safety data has not identified any safety concerns associated with the affected batches. Patients who have already received injections from the affected batches do not require any additional monitoring beyond routine clinical care unless they have concerns or experience new symptoms. Patients who experience adverse reactions or have any questions about their medication should seek medical attention
The products are indicated for the maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone. In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Paliperidone Mercury Pharma Prolonged Release suspension for injection may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.
Please refer to the following website in MHRA for details:http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-mercury-pharmaceuticals-ltd-paliperidone-mercury-pharma-prolonged-release-suspension-for-injection-in-pre-filled-syringes-el-26-a-slash-01#paliperidone-mercury-pharma-50-mg-prolonged-release-suspension-for-injection-in-pre-filled-syringe
In Hong Kong, Compassia Prolonged-Release Suspension For Injection In Pre-Filled Syringe 50mg/0.5ml (HK-68512), Compassia Prolonged-Release Suspension For Injection In Pre-Filled Syringe 75mg/0.75ml (HK-68513), Compassia Prolonged-Release Suspension For Injection In Pre-Filled Syringe 100mg/1ml (HK-68514) and Compassia Prolonged-Release Suspension For Injection In Pre-Filled Syringe 150mg/1.5ml (HK-68515) are pharmaceutical products containing paliperidone related to the affected products in the MHRA announcement, and are registered by Abbott Lab Ltd (Abbott). All products are prescription-only medicines. As confirmed by Abbott, the affected products recalled in the United Kingdom have not been launched in Hong Kong.
Ends/Wednesday, Jan 21, 2026
Issued at HKT 15:00
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