Letters and medicine recalls sent to healthcare professionals in December 2022

A summary of recent letters and notifications sent to healthcare professionals about medicines.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 25 January 2023

• Therapeutic area: Cardiovascular disease and lipidology, Dermatology, Dispensing GP practices, GI, hepatology and pancreatic disorders, Haematology, Infectious disease, Radiology and imaging, Urology and nephrology

Letters

In December 2022, the following letters were sent or provided to relevant healthcare professionals:

• Xaqua (metolazone) 5mg tablets: differences with other metolazone preparations and safety considerations required when switching patients – see article in January 2023 Drug Safety Update

• Lagevrio 200 mg hard capsules (molnupiravir) – Extended Use Beyond Labelled Expiry Date

• Kaftrio 75mg/50mg/100mg (ivacaftor/tezcaftor/elexacaftor) and Kalydeco 50mg, 75mg and 150mg film coated tablets (ivacaftor): Temporary Supply of stock to UK(NI) with blue box referencing Ireland only

• ONUREG 300mg Film-coated Tablets (oral azacitidine): Interim Supply of Northern Ireland (NI) Stock to Mitigate Supply Disruption

• Incorrectly labelled bottles of Bylvay (odevixibat) 1200 mcg Hard Capsules (PLGB 36216/0004) batch W067208E – Caution in Use

• Lymphoseek (tilmanocept) 50 micrograms kit for radiopharmaceutical preparation: temporary 17-month extension of shelf life of LOT 347446

• Discontinuation of Fragmin (Dalteparin Sodium) 10,000IU/1 ml ampoule (PL 00057/977)

Medicine Recalls and Notifications

In December 2022, recalls and notifications for medicines were issued on:

Class 4 Medicines Defect Information: ADVANZ PHARMA, MacroBID 100mg Prolonged-Release Capsules, EL (22)A/50. Issued 5 December 2022. Certain batches (see link for details) of MacroBID 100mg Prolonged-Release Capsules have been packed with the incorrect Patient Information Leaflet (PIL). There is no risk to product quality and efficacy, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing the affected batches and to provide patients with a copy of the Summary of Product Characteristics (SmPC).

Class 4 Medicines Defect Information: Galderma (U.K.) Limited, Etrivex 500 micrograms/g Shampoo, EL (22)A/51. Issued 6 December 2022. The patient information leaflet (PIL) packaged in specific batches (see link for details) of Etrivex Shampoo is missing safety information. There is no risk to product quality, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing the affected batches. Where possible, provide an updated copy of the PIL (link provided in letter) to the patient and remind them to read the leaflet in its entirety before using the medicine.

Class 4 Medicines Defect Information: Galderma (U.K.) Limited, Epiduo 0.1% / 2.5% gel (45 g), EL (22)A/52. Issued 19 December 2022. The Patient Information Leaflet (PIL) packaged in some batches of Epiduo 0.1% / 2.5% gel contains outdated safety information regarding pregnancy. There is no risk to product quality. Healthcare professionals are advised to exercise caution when dispensing the affected batches (see link for details) and, where possible, to provide an updated copy of the PIL and remind the patient to read the leaflet in its entirety before using the medicine.

The public consultation on how the MHRA communicates medicines and medical devices safety information to healthcare professionals is now open. The consultation is a unique opportunity to influence future MHRA safety communications and safety reporting systems so please encourage all healthcare professionals to complete the survey. The deadline for responses has been extended to 11.45pm on Tuesday 31 January.

Article citation: Drug Safety Update volume 16, issue 6: January 2023: 5.

Published 25 January 2023