Letters
In November 2021, the following letters were sent or provided to relevant healthcare professionals:
- Beovu ▼ (brolucizumab): updated recommendations to minimise the known risk of intraocular inflammation, including retinal vasculitis and/or retinal vascular occlusion
- Forxiga (dapagliflozin) 5mg should no longer be used for the treatment of Type 1 Diabetes Mellitus (see accompanying Drug Safety Update article)
- Mitocin (mitomycin) 20mg powder for solution for injection/infusion or intravesical use: new single-use filtration device must be used to avoid patient exposure to subvisible particles and reduce risk of injection reactions
- Zavedos (idarubicin) 5mg and 10mg Powder for Solution for Injection: Temporary supply of unlicensed 5mg/5ml and 10mg/10ml presentations to UK market; important differences in storage, preparation and administration
- Fluad Tetra (Influenza vaccine (surface antigen, inactivated, adjuvanted)) 0.5ml 10x1 PFS: Interim Supply to Great Britain to Mitigate Supply Disruption
Medicine Recalls and Notifications
In November 2021, recalls and notifications for medicines were issued on:
UPDATE: Class 4 Medicines Defect Information: Crescent Pharma Ltd, SyreniRing 0.120 mg/0.015 mg per 24 hours, vagin*l delivery system, EL (20)A/36. Issued 2 November 2021. Additional batches of SyreniRing 0.120 mg/0.015 mg (etonogestrel and ethinylestradiol) have been identified to contain Patient Information Leaflets missing important safety relevant text changes. An updated batch list has been included on the original defect notification issued in August 2020. Healthcare professionals dispensing this product should ensure patients are aware of any missing information.
Class 4 Medicines Defect Information: Vygoris Limited, Mitocin (mitomycin) 20mg powder for solution for injection/infusion or intravesical use, EL (21)A/27. Issued 8 November 2021. Some vials of Mitocin 20mg (mitomycin) powder for solution for injection/infusion or intravesical use may contain subvisible particles above the current specifications after reconstitution. The manufacturer will include a single-use filtration device with all future stock of Mitocin 20mg and healthcare professionals may request additional filters from the manufacturer. Healthcare professionals are advised to check existing stock and ensure that prior to treatment, the single-use filters are used.
. Issued 11 November 2021. Batches of Cold and Flu relief capsules (Paracetamol 300 mg, Caffeine 25 mg and Phenylephrine hydrochloride 5 mg) in various liveries are being recalled due to an error on the product carton and leaflet. The affected products incorrectly state the posology for individuals over 12 years as 2 capsules every 4 to 6 hours as required, up to a maximum of 12 capsules in any 24-hour period. This exceeds the paediatric paracetamol limits for children aged 12 – 15 years where the correct posology is up to a maximum of 8 capsules in any 24-hour period. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.
Class 4 Medicines Defect Information: Slenyto 1 mg and 5mg prolonged-release tablets – distributed by Flynn Pharma Ltd, EL (21)A/29. Issued 15 November 2021. Batches of Slenyto 1mg and 5mg (melatonin) prolonged-release tablets have been identified to be missing important safety relevant text from the Patient Information Leaflets. The Patient Information Leaflets in affected batches do not contain the interaction with beta-blockers or details of pack sizes. Healthcare professionals are advised to exercise caution when dispensing the product and where possible provide an updated Patient Information Leaflet to patients.
Company led medicines recall: Dotarem solution for injection (10ml Vial) - PL 12308/0016. Issued 17 November 2021. Batches of Dotarem (gadoteric acid) solution for injection 10ml vials are being recalled due to defects in the glass vial neck leading to leakage and potential loss of sterility. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.
Class 2 Medicines Recall: SANTEN Oy (trading as Santen UK Limited) and parallel distributor, IKERVIS 1 mg/mL eye drops, emulsion and VERKAZIA 1 mg/mL eye drops, emulsion, EL (21)A/30. Issued 18 November 2021. Batches of Ikervis 1mg/ml eye drops and Verkazia 1mg/mL eye drops (ciclosporin) are being recalled due to particles or crystals of the active ingredient detected during stability testing. No reports of adverse events have been received by the Marketing Authorisation Holder, but there is potential for ocular irritation, eye pain or foreign body sensation due to the presence of particles. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.
Class 3 Medicines Recall: Martindale Pharma, an Ethypharm Group Company Methadone 5mg Tablets / Physeptone 5mg Tablets, EL (21)A/31. Issued 22 November 2021. A batch of methadone 5mg tablets is being recalled as a precaution due to discolouration of the blister pockets film. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.
. Issued 29 November 2021. Batches of Diuril (chlorothiazide) oral solution have been identified with incorrect product information. The Patient Information Leaflet in affected batches states an incorrect alcohol content of 0.4%, whilst the bottle, carton and Patient Information Leaflet inside the pack correctly state 0.5% alcohol content. Healthcare professionals are advised to use caution when dispensing the product and use the manufacturers Patient Information Leaflet inserted in the pack.
Class 4 Medicines Defect Information: Mometasone Furoate 50 Microgram / Dose Nasal Spray, Suspension, PilsCo Ltd, EL (21)A/33. Issued 29 November 2021. Batches of mometasone furoate 50 microgram nasal spray have been identified with incorrect usage instructions. Affected batches contain a bottle label that incorrectly advises the product should be used within 2 weeks of first use, as the correct statement is to use within 2 months of first use. The correct wording is present in the Patient Information Leaflet and on the product carton. Healthcare professionals are advised to exercise caution when dispensing the product and instruct the patient to ensure they use the product within 2 months of first use.
Class 2 Medicines Recall: Various Marketing Authorisation Holders and parallel distributor companies, Irbesartan-containing products, EL(21)A/34. Issued 30 November 2021. Batches of the following medicines are being recalled by multiple manufacturers and distributors: Aprovel (irbesartan) 150mg and 300mg film-coated tablets, Co-Aprovel (irbesartan and hydrochlorothiazide) 150mg/12.5mg, 300mg/12.5mg Film-Coated Tablets. This is a precautionary recall as batches have been identified to contain 5-(4’-(azidomethyl)-[1,1’-biphenyl]-2yl)-1H-tetrazole, an impurity of mutagenic potential that is above the acceptable limits. Stop supplying the batches immediately, quarantine all remaining stock and return to supplier. Healthcare professionals should advise patients not to stop taking their medicine without consulting their doctor or pharmacist. The MHRA will provide further updates as our investigation progresses.
See Alerts, recalls and safety information for all recent notices.
Article citation: Drug Safety Update volume 15, issue 5: December 2021: 5.
Published 10 December 2021
