Archive for MHRA Updates
MHRA Safety Survey
Consultation on how we communicate with healthcare professionals to improve medicines and medical devices safety. Source: MHRA The MHRA is reviewing its approach to engagement with healthcare professionals to improve...
Class 3 Medicines Recall: Medreich PLC, Mebeverine hydrochloride 135mg Film-coated tablets, EL (22)A/46
Source: MHRA / Gov.uk 27.10.22 Medreich PLC UK is recalling a batch of Mebeverine hydrochloride 135mg film-coated tablets as a precautionary measure due to out of specification results for tablet...
Class 4 Medicines Defect Information: Recordati Rare Diseases, Pedea 5 mg/ml solution for injection, EL(22)A/45
Source: MHRA/ Gov.uk 25.10.22 Recordati Rare Diseases T/A Recordati Rare Diseases UK Ltd has made the MHRA aware that specific batches of Pedea 5 mg/ml solution for injection have been...
National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Targocid 200mg powder for solution for injection/infusion or oral solution, Aventis Pharma Limited t/a Sanofi, due to the presence of bacterial endotoxins, NatPSA/2022/008/MHRA
Source MHRA / Gov.uk 21.10.22 Sanofi UK is initiating an urgent recall of two batches of Targocid 200mg powder for solution for injection/infusion or oral solution ational Patient Safety Alert...
Class 2 Medicines Recall: hameln pharma ltd, Ephedrine Hydrochloride 30 mg/ml Solution for Injection, EL(22)A/44
Source: MHRA / Gov.uk 20.10.22 hameln pharma ltd is initiating a recall of the affected batches of Ephedrine Hydrochloride 30 mg/ml Solution for Injection as a precautionary measure. MDR number...
Class 4 Medicines Defect Information: Flamingo Pharma UK Ltd, Ibuprofen 400mg Tablets, Paracetamol 500mg Tablets (Caplets), EL (22)A/43
Source: MHRA / Gov.uk 12.10.22 Flamingo Pharma UK Ltd has identified an error relating to the ink printing of the batch number and expiry date on the carton for three...
Class 2 Medicines Recall: hameln pharma ltd, Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion, EL (22)A/42
Source: MHRA / Gov.uk 11.10.22 hameln pharma ltd is initiating a recall of batch 210505 of Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion as a precautionary measure MDR...
Class 2 Medicines Recall: Aventis Pharma Limited (t/a Sanofi), Stemetil 5mg/5ml Syrup, EL(22)A/41
Source: MHRA / Gov.uk 6.10.22 MDR number MDR 006-09/22 Company name Aventis Pharma Limited (t/a Sanofi) Product name Stemetil 5mg/5ml Syrup PL 04425/0595 Batch number Expiry date Pack size First...
Class 4 Medicines Defect Information: Rosemont Pharmaceuticals Ltd, Atorvastatin 4mg/ml Oral Suspension & Sildenafil 10mg/ml Oral Suspension , EL (22)A/39
Source: MHRA/Gov.uk MDR Number MDR 025-09/22 Company name Rosemont Pharmaceuticals Ltd. Product description Atorvastatin 4mg/ml Oral Suspension PL 00427/0256 Batch Number Expiry Date Pack Size First Distributed ATV21001 Apr-2024 150...
Class 4 Medicines Defect Information: Quadrant Pharmaceuticals Limited, Bezalip Mono 400mg Tablets, EL (22)A/38
Source: MHRA / Gov.uk 12.9.22 Quadrant Pharmaceuticals Limited have informed the MHRA of an error with the Patient Information Leaflets (PILs) that have been packaged in various parallel imported batches....
Class 2 Medicines Recall: Hikma Pharmaceuticals USA Inc, Lorazepam 2mg/ml Injection, Lorazepam 4mg/ml Injection (unlicensed medicines)
Source: MHRA / Gov.uk 30.8.22 Hikma Pharmaceuticals USA Inc are recalling the below batches due to an out of specification result with related substances during testing for retain samples. MDR...
Class 2 Medicines Recall: Sun Pharmaceutical Industries Europe BV, Zoledronic acid SUN 5mg solution for infusion, EL(22)A/34
Source: MHRA / Gov.uk 11.8.22 Sun Pharmaceuticals are recalling batches of zoledronic acid due to out of specification results observed for Particulate Matter Test during routine stability testing. MDR...
