Norgine Limited, MOVICOL Plain 13.7g powder for oral solution
Norgine Limited is recalling specific batches of product as a precautionary measure due to some units containing the incorrect amounts of active ingredients.
Medicine recalls
Medicine recalls, drug alerts and medical device warnings from the MHRA. 338 listed.
Class 4 Medicines Defect Notification: B. Braun Melsungen AG, Meropenem 1000 mg powder and solvent for solution for infusion
B. Braun Melsungen AG has notified the MHRA that errors have been identified in the Patient Information Leaflet (PIL) included in some batches of Meropenem 1000 mg powder and solvent for solution for infusion.
Class 4 Medicines Defect Notification: Martindale Pharmaceuticals Ltd, Clobazam Martindale Pharma 5 mg/5 mL and 10 mg/5 mL Oral Suspension 150ml
Martindale Pharmaceuticals has informed the MHRA of an error with the linear barcode of some batches of Clobazam 5mg/5mL and 10mg/5mL Oral Suspension 150mL.
Zentiva Pharma UK Limited, Fingolimod Zentiva 0.5 mg Capsules
Zentiva UK Pharma Limited are recalling one batch of Fingolimod Zentiva 0.5 mg Capsules (BN 4L01372H) as a precautionary measure due to a potential risk of contamination with metal particles.
Rectal catheters sold for personal use (gas and colic relievers): Do not use in infants, including for the treatment of colic, gas-related discomfort or constipation
Do not use rectal catheters sold for personal use (gas and colic relievers) in infants, including for colic, gas-related discomfort or constipation. Stop using these products immediately and dispose of any unused devices.
Class 4 Medicines Defect Notification: Neuraxpharm UK Ltd, Tuzulby prolonged-release chewable tablets
Neuraxpharm UK Ltd has informed the MHRA of missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for certain batches of Tuzulby prolonged release 20mg, 30mg and 40mg…
Class 4 Medicines Defect Notification: Macarthys Laboratories Ltd T/A Martindale Pharma, Xaggitin XL Prolonged-release Tablets
Macarthys Laboratories Ltd T/A Martindale Pharma has notified the MHRA of a manufacturing issue impacting several batches of Xaggitin XL Prolonged-release Tablets, due to the occurrence of incorrect tablet counts in the bottles.
Beckton Dickson UK Ltd, ChloraPrep 1mL applicator
Becton Dickinson UK Ltd are recalling batches of ChloraPrep 2% w/v / 70% v/v cutaneous solution 1mL applicators due to a potential breach of sterility in the packaging process.
Bristol Laboratories Limited, Phenoxymethylpenicillin 250 mg/5ml Sugar free Oral Solution BP
Bristol Laboratories Limited is recalling one batch (7124002) of Phenoxymethylpenicillin 250 mg/5 ml Oral Solution Sugar Free due to product labelling issues.
UPDATE: Class 4 Medicines Defect Notification: Relonchem Limited, Gabapentin Relonchem 50mg/ml Oral Solution
Relonchem Limited have informed the MHRA that particles have been observed inside some bottles of Gabapentin Relonchem Oral Solution, identified through a customer complaint.
Flamingo Pharma UK Ltd, Flucloxacillin Capsules BP 500mg
Flamingo Pharma UK Ltd have informed the MHRA that certain packs of Flucloxacillin Capsules BP 500mg contain the incorrect PIL. The affected packs contain the PIL for Amoxicillin 500mg Capsules instead of the PIL…
Class 4 Medicines Defect Notification: Brancaster Pharma Limited, Benzylpenicillin benzathine 1.2 Million I.U. and 2.4 Million I.U. powder for suspension for injection
Brancaster Pharma Limited has informed the MHRA that the Patient Information Leaflet (PIL) in the cartons for the batches listed in this notification were released with an outdated PIL.
Orbit Pharma Limited, Cyclizine Lactate 50 mg/ml Solution for injection
Orbit Pharma Limited is recalling a specific batch of Cyclizine Lactate 50 mg/ml Solution for injection as a precautionary measure due to Good Manufacturing Practice (GMP) deficiencies identified at the manufacturing site.
Class 4 Medicines Defect Notification: Cadila Pharmaceuticals Limited, Mirtazapine 30mg Tablets
Cadila Pharmaceuticals Limited has informed the MHRA of an error with the European Article Number (EAN) barcode on the cartons of a batch of Mirtazapine 30mg Film-Coated Tablets distributed in Crescent Pharma Limited livery.
Class 4 Medicines Defect Notification: Teva UK Ltd, Ponlimsi (Denosumab) 60mg Solution for Injection in Pre-filled Syringe
Teva UK Limited is reporting a labelling error on the carton for Ponlimsi (Denosumab) 60mg Solution for injection in Pre-filled Syringe. The carton states “For application to the skin” when the product is licensed…
Becton Dickinson UK Ltd, ChloraPrep 2% 1mL and ChloraPrep Frepp 2% 1.5mL applicators
Becton Dickinson UK Ltd are recalling batches of ChloraPrep 2% 1mL applicators and ChloraPrep Frepp 2% 1.5 mL applicators due to a potential breach of sterility in the packaging process.
Crescent Pharma Limited, Ramipril 2.5 mg Capsules
Crescent Pharma Limited is initiating a precautionary recall of one batch of Ramipril 2.5 mg Capsules following the identification of a potential packaging error at the manufacturing site.
Class 4 Medicines Defect Notification: Fresenius Medical Care Deutschland GmbH, balance 2.3% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
Fresenius Medical Care Deutschland GmbH have identified an error in the Braille printed on the outer label.
Class 4 Medicines Defect Notification: Milpharm Limited, Loperamide hydrochloride 2 mg Orodispersible Tablets
Milpharm Limited has identified a discrepancy in the Patient Information Leaflet (PIL) approved for Loperamide hydrochloride 2 mg Orodispersible Tablets.
Amarox Limited, Sertraline 100mg film-coated tablets
Amarox Limited is recalling one batch of Sertraline 100 mg film-coated tablets as a precautionary measure due to an error at the manufacturing site.
Omega Pharma Ltd, Napralief 250mg Gastro-Resistant Tablets
Omega Pharma Ltd is recalling specific batches of Napralief 250mg Gastro-Resistant Tablets due to missing text in Section 2 and Section 3 of the Patient Information Leaflet (PIL) and on the Carton in packs…
Class 4 Medicines Defect Notification: Doncaster Pharma Limited, Hiprex 1g tablets
Doncaster Pharma Limited has informed the MHRA of an error related to the Braille embossing on the outer packaging of certain parallel imported batches of Hiprex 1 g tablets (POM).
Crescent Pharma Limited, Ramipril 10mg capsules
Crescent Pharma Limited is recalling one batch of Ramipril 10mg Capsules as a precautionary measure due to a potential error at the manufacturing site.
Bio Products Laboratory Limited, Rabies, Human normal Immunoglobulin 500IU solution for Injection
Bio Products Laboratory Limited is recalling one batch of Human Rabies Immunoglobulin following a stability failure for this batch. The batch has shown a reduction in potency of the Human Rabies immunoglobulin.