Medicines Healthcare Products Regulatory Agency
Letters
In February 2023, the following letters were sent or provided to relevant healthcare professionals:
Medicine Recalls and Notifications
In February 2023, recalls and notifications for medicines were issued on:
Class 4 Medicines Defect Information: Reckitt Benckiser Healthcare (UK) Limited, Lemsip Max Cold and Flu Capsules, EL (23)A/04. Issued 22 February 2023. A typographical error has been identified on the end flap of the outer carton of some batches of Lemsip Max Cold & Flu Capsules. The content of paracetamol per capsule was stated as 500g (grams) instead of 500mg (milligrams). The paracetamol content of each capsule is correctly stated in Patient Information Leaflet (PIL). There is no risk to product quality and/or efficacy.
Class 4 Medicines Defect Information: Atnahs Pharma UK, Zestoretic 20mg/12.5mg Tablets, EL (23)A/05. Issued 27 February 2023. The Patient Information Leaflet (PIL) packaged in certain batches of Zestoretic 20mg/12.5mg Tablets contains outdated safety information. There is no risk to product quality as a result of this issue. Healthcare professionals are advised to exercise caution when dispensing the affected batch (batch number SB012, expiry date April 2024). Where possible, please provide patients with an updated copy of the PIL and remind them to read the leaflet in its entirety before using the medicine.
Company led medicines recall: Vertical Pharma Resources Ltd T/A IPS Pharma, Levothyroxine Oral Suspension (Various Strengths) [unlicensed medicine], CLMR(23)A/03. Issued 27 February 2023. IPS Pharma is recalling specific batches of levothyroxine oral suspension from pharmacies and impacted patients due to the concentration of levothyroxine being greater than the amount stated on the label. The products are supplied to a limited number of patients, and the manufacturer can fully trace the products distribution.
Medical Device Safety Information
A Device Safety Information page was published in February 2023 on the following topic:
Ethylene oxide (EO) is a gas commonly used for sterilisation of different types of medical devices. The sterilisation process consists of a number of highly controlled and monitored stages, including the removal of ethylene oxide after treatment. The amount of residual EO that is allowed has been set by the international standard ISO 10993-7:2008 according to contact time of the medical device with the person. These allowable limits were selected to ensure that any residual levels present on the medical device after sterilisation pose minimal risk. EO is a volatile chemical and following sterilisation, the presence of EO further decreases over time.
As a precautionary measure, following an MHRA assessment of currently available data on EO levels, alternative devices to the BD BodyGuard Microsets should be sought in users of 5kg bodyweight and below. This follows an amendment to the international standard which sets out the applicability of allowable limits of EO for neonates and infants on medical devices. The MHRA is not aware of any specific safety concerns with regards to the use of these devices. The manufacturer is currently working to assess whether the residual levels of EO are in line with amended limits for low weight children.
For all 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 16, issue 8: March 2023: 4.