Letters and medicine recalls sent to healthcare professionals in March 2022
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices. Includes a recent recall of Accuretic (quinapril hydrochloride and hydrochlorothiazide).
Recall of Accuretic (quinapril hydrochloride and hydrochlorothiazide)
On 28 March 2022, all Accuretic (quinapril hydrochloride and hydrochlorothiazide) tablets were recalled at pharmacy and wholesale level as a precautionary measure due to the observation of levels of N-nitroso-quinapril (an impurity) above the acceptable daily intake level.
As a result of the recall, Accuretic will not be available to dispense from pharmacies. Currently no information can be provided for when Accuretic will be available again.
Based on the available data, there is no immediate risk to patients who have been taking this medication. Advise patients undergoing treatment not to discontinue Accuretic without consulting with their prescriber, as there are potential risks associated with suddenly stopping treatment for blood pressure.
See to provide advice to prescribers on impact on patient treatment. For patients who are already taking Accuretic, it will not be possible to continue treatment and the prescribing healthcare professionals should review their hypertension treatment and switch patients to a suitable alternative.
Other Letters
In March 2022, the following letters were also sent or provided to relevant healthcare professionals:
Other Medicine Recalls and Notifications
In March 2022, recalls and notifications for medicines were issued on:
Class 3 Medicines Recall: Kyowa Kirin Services Ltd. Isotard 60mg XL Tablets, EL (22)A/10. Issued 2 March 2022. A batch of Isotard XL (Isosorbide-5-mononitrate) tablets are being recalled due to the presence of microfibres or crystals of the active ingredient present on the surface of the tablets. This is a precautionary recall and this issue has no impact on tablet efficacy, product or patient safety. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.
Class 2 Medicines Recall: Wockhardt UK Ltd, Diazepam RecTubes 2.5mg Rectal Solution, EL (22)A/11. Issued 7 March 2022. A batch of Diazepam RecTubes 2.5mg Rectal Solution is being recalled due to out of specification results during stability testing. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.
Class 4 Medicines Defect Information: Boots Company Plc, Decongestant Tablets and Decongestant with Pain Relief Tablets, EL (22)A/12. Issued 10 March 2022. Batches of Decongestant (Pseudoephedrine hydrochloride) tablets and Decongestant with Pain Relief Tablets (Paracetamol, Pseudoephedrine hydrochloride) have been identified that omits safety information from the Patient Information Leaflet. The omitted information includes contraindications in pregnancy and breastfeeding and side effects of ischaemic colitis and ischaemic optic neuropathy. Healthcare professionals dispensing any of the affected batches are asked to provide the correct Patient Information Leaflet, to ensure that appropriate patient counselling takes place and patients are aware of the missing information.
Class 4 Medicines Defect Information: CNX Therapeutics Ltd, Latuda film-coated tablets, EL (22)A/13. Issued 14 March 2022. The MHRA has been informed that batches of Latuda (lurasidone) 18.5mg, 37mg and 74mg film-coated tablets will be released without the EAN barcodes on the cartons. The expected distribution dates for these batches will take place between April 2022 and July 2022. Wholesalers and healthcare professionals should refer to the batch number and expiry date printed on the carton for stock control and dispensing.
Class 4 Medicines Defect Information, Ayrton Saunders Limited, Beclometasone dipropionate 50 micrograms/dose Nasal Spray (Various Liveries), EL (22)A/14. Issued 15 March 2022. Batches of beclometasone dipropionate 50 micrograms / dose nasal spray in various liveries have been identified with incorrect braille, see the notification for full details. There is no issue with product quality and as these products are supplied as a single strength there are no possibilities of a dosing error occurring due to the error in the Braille. Healthcare professionals should explain the errors to patients who rely solely on Braille when reading medicine cartons.
Company led medicines recall: Advanced Accelerator Applications NETSPOT (Kit for the preparation of gallium Ga 68 dotatate injection) [unlicensed medicine], CLMR (22)A/02. Issued 16 March 2022. Batches of NETSPOT (kit for the preparation of gallium Ga 68 dotatate injection) are being recalled by the company due to out-of-specification results obtained during stability studies. This is an unlicensed medicine and the manufacturer has full traceability. Stop supplying the batch immediately, quarantine all remaining stock and return to the company.
Class 4 Medicines Defect Information: Benzylpenicillin benzathine 1.2 Million I.U. and 2.4 Million I.U. powder and solvent for suspension for injection, EL (22)A/15. Issued 17 March 2022. Batches of benzylpenicillin benzathine 1.2 Million and 2.4 million I.U. powder and solvent for suspension for injection have been identified with French labels on the 5mL ampoule of the water for injections solvent. The label on the vials, outer carton and Patient Information Leaflets are correct. Healthcare professionals are advised to note this issue.
Medical Device Safety Information
A recent MHRA National Patient Safety Alert has been published on:
National Patient Safety Alert: Philips Health Systems V60, V60 Plus and V680 ventilators: potential unexpected shutdown leading to complete loss of ventilation (NatPSA/2022/002/MHRA). Issued 29 March 2022. Philips Health Systems have informed the MHRA of the risk of potential unexpected shutdowns of V60 and V60 Plus non-invasive ventilators, and V680 invasive ventilators used in critical care settings. The safety concern identified relates to a number of electrical faults in the devices, which can result in an unexpected shutdown, leading to loss of ventilation. If unnoticed by healthcare professionals, ventilation failure can have a severe health impact on patients. To manage this risk, the National Patient Safety Alert includes actions for all hospital trusts and other healthcare providers using the affected ventilators to be completed by 31 May 2022.
For all of the latest safety notices from the MHRA on drugs and medical devices, see Alerts and recalls for drugs and medical devices.
Article citation: Drug Safety Update volume 15, issue 9: April 2022: 3.