Medicines Healthcare Products Regulatory Agency
Letters
In July 2023, the following letters were sent or provided to relevant healthcare professionals:
Medicine Recalls and Notifications
In July 2023, recalls and notifications for medicines were issued on:
Class 3 Medicines Recall: Strandhaven Limited T/A Somex Pharma, Sildenafil 100mg Film-coated Tablets, EL(23)A/21. Issued 3 July 2023. Strandhaven Limited T/A Somex Pharma has informed the MHRA that the pack size on some cartons of the batch in this notification state 8 tablets instead of 4 tablets. This is an error due to cartons being mixed at the printers. Stop supplying and quarantine any stock with this batch number that is labelled as containing 8 tablets. The packs labelled as 4 tablets can be dispensed as normal.
Class 2 Medicines Recall: medac GmbH (t/a medac Pharma LLP), Dacarbazine 100mg, 200mg & 500mg powder for solution for injection vials, EL(23)A/22. Issued 4 July 2023. medac GmbH (t/a medac Pharma LLP) is recalling the products and respective batches in this notification due to pink discolouration of the dacarbazine solution immediately after reconstitution (after correct preparation and storage). The pink discolouration is caused by a degradation product of dacarbazine and may cause a venous irritation in the patient when the product is applied. As stated in the Summary of Product Characteristics (SmPC), the diluted solution for infusion should be visually inspected and only clear solutions practically free from particles should be used. Do not use the solution if particles are present. Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your suppliers approved process.
Class 2 Medicines Recall: Tillomed Laboratories Limited, Labetalol 200mg Tablets, EL(23)A/23. Issued 10 July 2023. Tillomed Laboratories Limited is recalling one batch of Labetalol 200mg Tablets due to an error on the foil blister packaging. The incorrect aluminium foil blister packaging states Labetalol 100mg Tablets, however it should be labelled as Labetalol 200mg Tablets. Stop supplying the affected batches immediately. Quarantine all remaining stock and return it to your supplier using your suppliers approved process.
Class 4 Medicines Notification, Cipla (UK) Limited and Pharmathen S.A., Various Products, EL(23)A24. Issued 12 July 2023. Cipla (EU) Limited, UK has informed the MHRA that the outer carton (box) of the product batches mentioned in this notification are missing the medicines legal classification for a Prescription Only Medicine POM. Exercise caution when handling the listed products and ensure that they are stored accordingly and in line with the guidance for the storage of Prescription Only Medicines (POM). Only dispense these products when the pharmacy team receives a suitable prescription prescribed by a qualified health professional.
Class 2 Medicines Recall: Aventis Pharma Limited (t/a Sanofi), Sabril 500 mg film-coated tablets & Sabril 500 mg granules for oral solution, EL(23)A/25. Issued 13 July 2023. Sanofi UK is recalling the listed batches of Sabril tablets and Sabril granules as a precautionary measure due to the detection of traces of tiapride in the batches of the source material. Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your suppliers approved process. All patients should be advised not to discontinue Sabril tablets or Sabril granules without consulting with their prescriber. The risks of suddenly stopping medication for seizures/epilepsy is higher than the potential risk presented by the presence of tiapride.
Company led medicines recall: Quantum Pharmaceutical, Diltiazem HCl 2% Cream [unlicensed medicine], CLMR (23)A/05. Issued 19 July 2023. Quantum Pharmaceutical has informed the MHRA that the consistency of the product within the batches mentioned in this notification has changed. The product has a reduced viscosity and more closely resembles a lotion than a cream. Stop supplying the batches above immediately. Quarantine all remaining stock and liaise with Quantum Pharmaceutical on the return process. Quantum Pharmaceuticals has full traceability and will contact pharmacy teams that have been provided the affected products.
Class 2 Medicines Recall: medac GmbH (t/a medac Pharma LLP), Sodiofolin 50 mg/ml solution for injection/infusion (400mg/8ml vial), EL (23)A/26. Issued 20 July 2023. medac GmbH (t/a medac Pharma LLP) is recalling the products and respective batches in this notification due to particles detected during long-term stability tests. As stated in the Summary of Product Characteristics (SmPC): Only clear solutions without visible particles should be used. These batches are being recalled as a precautionary measure and the root cause investigation remains ongoing. Stop supplying the affected batches immediately. Quarantine all remaining stock and return it to your supplier using your suppliers approved process.
Class 2 Medicines Recall: B. Braun Medical Ltd, Various Products, EL(23)A/27. Issued 31 July 2023. B. Braun Medical Limited is recalling various product batches as a precautionary measure after traces of midazolam were detected in the batches listed in this notification. A toxicological assessment has been completed to evaluate the potential risk for patients. The assessment concluded that the highest detected levels of midazolam are deemed to display no clinical effects. Nevertheless, although at low risk, allergic reactions to Midazolam cannot be excluded. B. Braun Medical Limited has not received any reports of suspected adverse drug reactions for the affected batches. Stop supplying the listed batches immediately. Quarantine all remaining stock and return it to your supplier using your suppliers approved process. Based on the distribution dates, most of the affected stock will have been used already. B. Braun has confirmed that other stock which is not impacted remains available.
Article citation: Drug Safety Update volume 17, issue 1: August 2023: 4.