Letters and medicine recalls sent to healthcare professionals in June 2021

A summary of letters and drug alerts recently sent to healthcare professionals.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 7 July 2021

• Therapeutic area: Cancer, Cardiovascular disease and lipidology, Endocrinology, diabetology and metabolism, Haematology and Obstetrics, gynaecology and fertility
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  Pain management and palliation, Psychiatry, Respiratory disease and allergy, and Urology and nephrology

Letters

In June 2021, the following letters were sent or provided to relevant healthcare professionals:

• Venetoclax▼ (Venclyxto): updated recommendations on tumour lysis syndrome (TLS) in CLL patients
• Iloprost 100 micrograms/ml concentrate for solution for infusion – medication error: risk of underdosing due to ampoule labelling
• Inrebic ▼ (fedratinib) 100 mg hard capsules: Potential interaction with grapefruit or grapefruit juice
• Venlafaxine hydrochloride (ViePax XL 150 mg prolonged-release tablets): change of tablet appearance and formulation
• Xaluprine 20mg/ml oral suspension (mercaptopurine monohydrate): interim supply of Ireland stock to mitigate supply disruption
• Clenil Modulite (beclometasone): release of additional batches for all strengths using the standard colours of the inhaler actuators with no dose indicator
• Evorel Sequi (estradiol, norethisterone acetate): discrepancy in marketing authorisation number on the Evorel 50 pouch (PL 49105/0006) within the Evoral Sequi carton (PL 49105/0010) for a limited number of batches

Medicine Recalls and Notifications

In June 2021, recalls and notifications for medicines were issued on:

Company led medicines recall: Noidecs T20/C4 (THC 20%; CBD <4%) Indica Cannabis Flower (unlicensed medicine) and Noidecs T20/C4 (THC 20%; CBD <4%) Sativa Cannabis Flower (unlicensed medicine). Issued 09 June 2021. A batch of Noidecs T20/C4 Indica Cannabis Flower, and a batch of sativa cannabis flower are being recalled due to potential contamination with mould. The affected batches of these unlicensed medicines are being recalled as a precautionary measure. Stop supplying the batches immediately, quarantine all remaining stock and return to supplier.

National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Co-codamol 30/500 Effervescent Tablets, Batch 1K10121, Zentiva Pharma UK Ltd, due to precautionary risk of causing overdose, NatPSA/2021/004/MHRA. Issued 16 June 2021. A batch of Co-codamol 30/500 Effervescent Tablets is being recalled due to varying levels of active ingredients present in the tablets. An investigation has identified tablets with lower levels of the active ingredients codeine and paracetamol than displayed on the label, and there is also a potential risk for some tablets to contain higher levels of these active ingredients. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier. Healthcare professionals should contact all patients dispensed the affected batch and request them to urgently return the tablets for a replacement, and also advise patients to report any side effects to the MHRA Yellow Card scheme.

Class 2 Medicines Recall: Bristol Laboratories Limited, Brown & Burk UK Ltd, Teva UK Ltd, Irbesartan-containing and Losartan-containing products, EL (21)A/14. Issued 17 June 2021. Batches of the following medicines are being recalled by multiple manufacturers: irbesartan 75mg, 150mg and 300mg film coated tablets; losartan potassium 50mg and 100mg film coated tablets; irbesartan/hydrochlorothiazide 150mg/12.5mg, 300mg/12.5mg and 300mg/25mg film coated tablets. This is a precautionary recall as batches have been identified to be contaminated with an impurity of mutagenic potential. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier. The MHRA will provide further updates as our investigation progresses. Healthcare professionals should advise patients not to stop taking their medicine without consulting their doctor or pharmacist.

Medical Device Safety Information

A recent MHRA National Patient Safety Alert has been published on:

• National Patient Safety Alert: Philips ventilator, CPAP and BiPAP devices: Potential for patient harm due to inhalation of particles and volatile organic compounds (NatPSA/2021/005/MHRA)

There was also a recent MHRA Device Safety Information page published on:

• Medical devices sterilised by Steril Milano – potential for incomplete sterilisation (DSI/2021/008)

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 14, issue 12: July 2021: 5.

Published 7 July 2021