Letters and medicine recalls sent to healthcare professionals in October 2021

A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 16 November 2021

• Therapeutic area: Cancer, Cardiovascular disease and lipidology, Dispensing GP practices, Ear, nose and throat and Endocrinology, diabetology and metabolism
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  Immunology and vaccination, Infectious disease, Ophthalmology, Paediatrics and neonatology, and Respiratory disease and allergy

Letters

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

• Emerade 300 microgram and 500 microgram adrenaline auto-injectors: re-supply to market – important safety information (see accompanying Drug Safety Update article)
• Stamaril (live attenuated yellow fever vaccine): reminder of the indication, contraindications, recommendations and warnings for use to ensure appropriate evaluation of risk-benefit before vaccination – Yellow Fever vaccine checklist to be completed prior to administration of each traveller (see accompanying Drug Safety Update article)
• Champix (varenicline) - batches to be recalled due to presence of impurity N-nitroso-varenicline above the acceptable intake limit
• Synagis solution for injection (palvizumab): Interim supply of 100mg/1ml Italian stock; 50mg/0.5ml Turkish stock to mitigate supply disruption
• Tukysa (tucatinib) 50mg and 150mg film-coated tablets: Interim Supply of French or German/Austrian Stock

We also note the following letter issued to healthcare professionals in November 2021:

• Forxiga (dapagliflozin) 5mg should no longer be used for the treatment of Type 1 Diabetes Mellitus

Medicine Recalls and Notifications

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

Company led medicines recall: Glucose 10%w/v 10ml injection (unlicensed medicine) and Trometamol 7%w/v injection 5mL (unlicensed medicine). Issued 4 October 2021. Batches of Glucose 10% w/v injection 10mL and Trometamol 7%w/v injection 5mL are being recalled due to limited assurance of product sterility. This is a precautionary recall. The affected stock should be quarantined when replacement is available.

Class 2 Medicines Recall: Tesco Flu-Max All In One Chesty Cough & Cold Powder for Oral Solution Wrafton Laboratories Limited (trading as Perrigo) EL (21)A/24. Issued 12 October 2021. Batches of Tesco Flu-Max all in one chesty cough and cold powder for oral solution are being recalled due to an error on the product sachet. The affected sachets incorrectly state that the product can be used in children 12 years and over, whilst the product information and carton correctly state this product should not be given to children under 16 years old. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.

Class 2 Medicines Recall: Pfizer Ltd, Champix (all strengths) film-coated tablets, EL (21)A/25. Issued 14 October 2021. Batches of Champix 0.5mg film-coated tablets, 0.5mg + 1mg film coated tablets and 1mg film-coated tablets are being recalled. This is a precautionary measure due to the presence of levels of N-nitroso-varenicline above acceptable levels. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier. Healthcare professionals should advise patients undergoing treatment with Champix to discuss and questions or concerns with their prescriber.

Company led medicines recall: Irinotecan 200mg/ 260mL in sodium chloride 0.9% w/v intravenous infusion and Infliximab (Remsima) intravenous infusion in sodium chloride 0.9% Issued 21 October 2021. A single batch of Irinotecan 200mg/ 260mL in sodium chloride 0.9% w/v intravenous infusion and several batches of Infliximab (Remsima) intravenous infusion in sodium chloride are being recalled due to reduced product stability and reduced product sterility respectively. Hospital pharmacies should stop supplying the batch immediately, quarantine all remaining stock and return to supplier once replacement stock is available.

Class 3 Medicines Recall: Bimatoprost Aspire 0.3mg/ml eye drops, solution in single-dose container, Aspire Pharma Limited, EL (21)A/26. Issued 26 October 2021. Batches of Bimatoprost Aspire 0.3mg/ml eye drops are being recalled due to variability in plastic thickness of the single dose containers. This is a precautionary recall as some patients find the defective containers difficult to squeeze to access the product. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.

We also note the recent Class 2 recall (issued 11 November) of Cold & Flu Relief Capsules available on general sale. Perrigo are recalling the listed batches available under various liveries due to an error on the leaflet and carton stating an incorrect maximum daily dose for patients aged 12–15 years. MHRA considered the safety assessment for 12 to 15 year olds who may have taken the incorrect daily dose as very low and there is no evidence of any harm, therefore this recall is not direct to patient level. Retailers and wholesalers have been asked to stop supplying the batches immediately, quarantine all remaining stock and return to supplier.

See Alerts, recalls and safety information for all recent notices.

Article citation: Drug Safety Update volume 15, issue 4: November 2021: 4.

Published 16 November 2021