Letters and medicine recalls sent to healthcare professionals in October 2023

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

• From: Medicines and Healthcare products Regulatory Agency
• Published: 23 November 2023

• Therapeutic area: Anaesthesia and intensive care, Dispensing GP practices, Infectious disease, Neurology, Psychiatry, Respiratory disease and allergy

Letters

In October 2023, the following letters were sent or provided to relevant healthcare professionals:

• Salbutamol 2mg/ml nebuliser solution – temporary supply of unlicensed imported product
• Guanfacine hydrochloride, Intuniv ▼ 1mg, 2mg, 3mg, 4mg prolonged-release tablets: Expected shortage
• OctaplasLG infusion 200ml bags (Blood Group A) (Human plasma proteins 57.5mg per ml): Interim Supply of Germany Stock to Mitigate Supply Disruption
• Oral isotretinoin▼: New safety measures following review into sexual and psychiatric adverse reactions

Medicine Recalls and Notifications

In October 2023, recalls and notifications for medicines were issues on:

Class 4 Medicines Defect Information: Sandoz Limited, Zinacef powder for solution for injection or infusion vials (all strengths, including stock in GSK livery), EL (23)A/38. Issued on 23 October 2023. Sandoz has detected that information on the diluents in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) of cefuroxime offer possibility for both intramuscular (IM) and intravenous (IV) administration. The PIL and SmPC state that cefuroxime sodium is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride. However, dilution with lidocaine is intended only for intramuscular (IM) use. The corrected instructions (for future PILs and SmPCs) are detailed in the alert.

Article citation: Drug Safety Update Volume 17, issue 4: November 2023:4.

Published 23 November 2023