Archive for MHRA Updates
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...
Company led medicines recall: Stockport Pharmaceuticals, Sodium Chloride Eye Drops 5% 1x10ml (unlicensed medicine), CLMR (22)A/06
Source: MHRA / Gov.uk 8.8.22 Stockport Pharmaceuticals are recalling a batch of Sodium Chloride Eye Drops 5% w/v as the sterile eye droppers supplied with the medicinal product have expired...
National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Mexiletine hydrochloride 50mg, 100mg and 200 mg Hard Capsules, Clinigen Healthcare Ltd, due to a potential for underdosing and/or overdosing
Source: MHRA / Gov.uk 4/8/22 Clinigen Healthcare Ltd is initiating a recall of three batches of Mexiletine hydrochloride hard capsules due to a potential risk of underdose or overdose, which...
Statement of amendments to annual flu letter – 21 July 2022
Source: UK Health Security Agency, NHS England, and Department of Health and Social Care The NHS influenza immunisation programme 2022 to 2023 (‘annual flu letter’) of the 22 April 2022 is hereby...
Class 4 Medicines Defect Information: Novo Nordisk Limited, NovoRapid® FlexTouch® 100 units/ml, Saxenda® FlexTouch® (liraglutide) 6mg/ml, EL(22)A/33
Source: Gov.uk / MHRA 21.7.22 Novo Nordisk Limited would like to notify you of a defect that affects specific batches of NovoRapid FlexTouch prefilled pen device and batches of Saxenda...
Class 4 Medicines Defect Information: Omega Pharma Limited, Niquitin 14mg Clear Patch (14 patches), EL(22)A/32
Source: Gov.uk / MHRA 20.7.22 Omega Pharma Limited have identified an error relating to the product packaging. MDR Number MDR 041-07/22 Company name Omega Pharma Limited Product description Niquitin 14mg...
