GovWire

Letters

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

• Imbruvica (ibrutinib): New risk minimisation measures, including dose modification recommendations, due to the increased risk for serious cardiac events
• Stemetil (Prochlorperazine mesilate) 5 mg / 5 ml Syrup: permanent discontinuation due to laboratory test results demonstrating excess levels of N?nitrosomethylphenylamine
• Vincristine sulfate 1 mg/1 ml solution for injection (PL 04515/0008) 2 mg in 2 ml Temporary supply of US stock of Vincristine sulfate Injection, USP 2 mg/2 ml (batch number GD0903AA) to mitigate supply disruption
• NovoRapid Penfill 100 units/ml solution for injection in cartridge (insulin aspart): supply of Stock with old Patient Information Leaflet to mitigate supply disruption in November 2022

Medicine Recalls and Notifications

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

National Patient Safety Alert: Class 4 Medicines Defect Information: Prenoxad 1mg/ml Solution for Injection, Macarthys Laboratories (Aurum Pharmaceuticals Ltd/Ethypharm Group), due to potential missing needles in sealed kits, NatPSA/2022/009/MHRA. Issued 10 November 2022. Macarthys Laboratories (trading as Martindale Pharma, an Ethypharm Group Company), has notified the MHRA of a limited number of Prenoxad packs in a batch marketed in France with missing needles. Healthcare professionals and service providers should note the actions set out the alert before supplying Prenoxad kits.

Class 4 Medicines Defect Information: Macarthys Laboratories t/a Martindale Pharma, Venlafaxine XL 300 mg prolonged-release tablets, EL(22)A/47. Issued 16 November 2022. Martindale Pharma has made the MHRA aware that the GTIN in the 2D barcode and the printed variable data represents the branded version of the product (Venlalic XL 300 mg prolonged-release tablets). Healthcare professionals are advised to exercise caution when dispensing the products. Additional precautions should be considered by wholesalers and pharmacies using automated inventory systems to dispense the affected batch within the pharmacy or wholesale facility.

Class 4 Medicines Defect Information: Morningside Healthcare Limited, Hyoscine Butylbromide 20 mg Film-coated Tablets, EL (22)A/48. Issued on 21 November 2022. Morningside Healthcare Limited has informed the MHRA of an error with the Patient Information Leaflet (PIL) packaged in batch 22237001 of Hyoscine Butylbromide 20 mg Film-coated Tablets. Healthcare professionals are advised to exercise caution when dispensing the above batch and to check the PIL. If the pack contains the wrong PIL, remove and destroy it and provide a copy of the correct PIL.

Class 4 Medicines Defect Information: Lucis Pharma Ltd, Oxycodone Hydrochloride 10mg/ml oral solution, EL (22)A/49. Issued 29 November 2022. Lucis Pharma Ltd has informed the MHRA that there is a typographical error with text on the rear side of the outer packaging for Oxycodone Hydrochloride 10mg/ml Oral Solution. Healthcare professionals should exercise caution when dispensing or supplying this product. Please refer to the correct information stated on the bottle label and in the Patient Information Leaflet inserted in the pack.

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.

Article citation: Drug Safety Update volume 16, issue 5: December 2022: 3.