Archive for MHRA Updates
Class 4 Medicines Defect Information: Takeda UK Limited, Entyvio 108mg solution for injection in pre-filled syringe, EL(24)A/55
Source: MHRA/ Gov.uk 18.11.24 Takeda UK Limited has informed the MHRA that there is an error in the Patient Information Leaflet for specified batches of Entyvio 108mg pre-filled syringes. DMRC...
Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices
Source: MHRA / Gov.uk 14.11.24 The MHRA is inviting members of the public to provide their views on proposed changes to the regulatory framework for medical devices. This consultation closes...
Company led medicines recall: Leeds Trading Company LTC Ltd T/A LTC Healthcare, EXS Delay Spray Plus, CLMR(24)A/01
Source: MHRA/Gov.uk 13.11.24 LTC Healthcare has informed the MHRA that they have been selling a medicinal product containing lidocaine without authorisation from the MHRA. CLMR Number CLMR (24)A/01 DMRC Reference...
Class 4 Medicines Defect Information: Viatris UK Healthcare Ltd, Omeprazole 40 mg Powder for solution for infusion, EL(24)A/54
Source: MHRA/Gov.uk 12.11.24 Generics (U.K.) Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in specific batches of Omeprazole 40 mg Powder for solution for infusion do...
Class 4 Medicines Defect Information: Ennogen Healthcare Limited, Zoledronic Acid Ennogen 4mg/5ml concentrate for solution for infusion, EL (24)A/53
Source: MHRA /Gov.uk Ennogen Healthcare Limited has identified that action had not been taken to ensure the Patient Reminder Card (PRC) was distributed alongside the packs of product as part...
Class 2 Medicines Recall: Tillomed Laboratories Limited, Labetalol 200mg Tablets, EL(24)A/52
Source: MHRA/Gov.uk 31.10.24 Tillomed Laboratories Limited is recalling one batch of Labetalol 200mg Tablets as a precautionary measure due to potential mix-up at the manufacturing site. DMRC reference number DMRC-33718718...
Class 2 Medicines Recall: Tillomed Laboratories Limited, Labetalol 200mg Tablets, EL(24)A/52
Source: MHRA/ Gov.uk 29.10.24 Tillomed Laboratories Limited is recalling one batch of Labetalol 200mg Tablets as a precautionary measure due to potential mix-up at the manufacturing site. DMRC reference number...
Class 4 Medicines Defect Information: Kent Pharma UK, Parasolve (Paracetamol) 500mg effervescent tablets, EL(24)A/51
Source: MHRA/ Gov.uk 28.10.24 Kent Pharma UK has identified an error in the Patient Information Leaflet (PIL) for Paracetamol 500mg Effervescent Tablets. DMRC reference number DMRC-32772688 Company name Kent Pharma...
UPDATE: Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Ltd Cyanocobalamin 50 mcg Tablets, EL(24)A/46
Source: MHRA/Gov.uk 24.10.24 Glenmark Pharmaceuticals Europe Ltd is recalling the affected batches as a precautionary measure due to out of specification results for unknown impurities during routine stability testing and...
Class 2 Medicines Recall: Bristol Laboratories Ltd, Phenobarbital Bristol Labs 15mg Tablets, EL(24)A/50
Source: MHRA/Gov.uk 23.10.24 Bristol Laboratories Ltd. are recalling one batch of Phenobarbital Bristol Labs 15mg Tablets as a precautionary measure due to the potential of contamination of small metallic particles...
Class 4 Medicines Defect Information: Kent Pharma UK, Paracetamol 500mg Effervescent Tablets, EL(24)A/49
Source: MHRA/ Gov.uk 21.10.24 DMRC reference number DMRC-32772688 Company name Kent Pharma UK Paracetamol 500mg Effervescent x100 Tablets (P), PL 51463/0031 SNOMED Codes 1856211000001101 (5×20) 1856011000001106 (10×10) Paracetamol 500mg Effervescent...
Class 4 Medicines Defect Information: Sandoz Ltd., Linezolid 600 mg film-coated tablets, EL(24)A/48
Source: MHRA/Gov.uk 10.10.24 Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for Linezolid 600...
