Letters and medicine recalls sent to healthcare professionals in December 2022
A summary of recent letters and notifications sent to healthcare professionals about medicines.
Letters
In December 2022, the following letters were sent or provided to relevant healthcare professionals:
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). 皇冠体育appre 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. 皇冠体育app patient information leaflet (PIL) packaged in specific batches (see link for details) of Etrivex Shampoo is missing safety information. 皇冠体育appre 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. 皇冠体育app Patient Information Leaflet (PIL) packaged in some batches of Epiduo 0.1% / 2.5% gel contains outdated safety information regarding pregnancy. 皇冠体育appre 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.
皇冠体育app public consultation on how the MHRA communicates medicines and medical devices safety information to healthcare professionals is now open. 皇冠体育app 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. 皇冠体育app 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.