Paliperidone Mercury Pharma prolonged-release suspension recalled over a packaging defect

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(26)A/01). Quoted as issued.

Summary

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.

The risk

DMRC reference number DMRC-37923982 Marketing Authorisation Holder

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.

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. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .

Advice for 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. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .

Open the MHRA notice