Letters and medicine recalls sent to healthcare professionals in April 2022
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices. Includes a recent recall of Accupro (quinapril hydrochloride) and advice on Xagrid (anagrelide hydrochloride).
Recall of Accupro (quinapril hydrochloride)
On 5 May 2022, all Accupro (quinapril hydrochloride) 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, Accupro will not be available to dispense from pharmacies. Currently no information can be provided for when Accupro 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 Accupro without consulting with their prescriber, as there are potential risks associated with suddenly stopping treatment for blood pressure.
See accompanying letter to provide advice to prescribers on impact on patient treatment. For patients who are already taking Accupro, 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.
Xagrid (anagrelide hydrochloride): Risk of thrombosis if treatment discontinued abruptly
Anagrelide hydrochloride is indicated for the reduction of elevated platelet counts in at-risk patients with essential thrombocythaemia who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy. Following a European review, new warnings were introduced to avoid abrupt discontinuation and .
There is an increased risk of thrombotic complications, including cerebral infarction, if anagrelide treatment is discontinued abruptly. In the event of dosage interruption or treatment withdrawal, monitor platelet counts frequently.
Other letters
Other Medicine Recalls and Notifications
In April 2022, recalls and notifications for medicines were issued on:
Class 2 Medicines Recall: USV UK Limited, Olopatadine USV 1mg/ml Eye Drops, Solution, EL(22)A/17. Issued 11 April 2022. Batches of Olopatadine (olopatadine hydrochloride) USV 1mg/mL eye drops are being recalled due to out of specification results for impurities during stability testing. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.
Class 4 Medicines Defect Information: Pfizer Limited, Depo-Medrone with Lidocaine 40 mg/mL (1 mL and 2 mL vials – single vial preparations), EL (22)A/18. Issued 21 April 2022. Batches of Depo-Medrone with Lidocaine (Methylprednisolone acetate and Lidocaine hydrochloride) 40 mg/mL have been identified to contain an out-dated Patient Information Leaflet. The leaflets contains omits information including warning and precautions and risk of low birth weight of the baby if used in pregnancy, and the leaflet contains out of date adverse reaction frequencies. Healthcare professionals administering medicine from 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 2 Medicines Recall: Crescent Pharma Limited, Paroxetine 40mg Film Coated Tablets, EL(22)A/19. Issued 27 April 2022. A batch of paroxetine 40mg film coated tablets is being recalled due to out of specification results for dissolution during routine stability testing. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.
Class 2 Medicines Recall: Fresenius Kabi Limited, Sodium bicarbonate 1.26% Solution for infusion, EL(22)A/20. Issued 28 April 2022. A batch of Sodium bicarbonate 1.26% Solution for infusion is being recalled as a precautionary measure due to identification of particles in the solution for infusion. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.
Medical Device Safety Information
In April 2022, MHRA Device Safety Information pages have been published on:
Paclitaxel drug-coated balloons (DCBs) or drug-eluting stents (DESs): Updated position on use in patients with critical limb ischaemia and intermittent claudication DSI/2022/003. Issued 5 April 2022. In 2021 the MHRA convened an independent Expert Advisory Group to review new evidence for paclitaxel drug-coated balloons and paclitaxel drug eluting stents. The MHRA’s recommendations for using paclitaxel-coated devices in patients with intermittent claudication and critical limb ischaemia have been updated to take into account potential dose dependent effects of paclitaxel coated balloons and stents in patients. Actions for clinicians are available in the device safety information.
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 10: May 2022: 3.