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Relonchem Limited have informed the MHRA that particles have been observed inside some bottles of Gabapentin Relonchem Oral Solution, identified through a customer complaint.
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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 for Fluclox…
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…This is linked to the Class 2 Medicines Notification EL(25)A/22. This defect could increase the risk of the applicator device being contaminated with pathogens.…
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…Additional to the batches included in the previous Class 4 Medicines Notification (reference EL(22)A/47), 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 prolonged-release…
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The MHRA has re-issued this notification as Class 3 recall based on further assessment. Please note the new actions for healthcare professionals listed within the notification.…
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Bristol Laboratories Limited is recalling one batch (7124002) of Phenoxymethylpenicillin 250 mg/5 ml Oral Solution Sugar Free due to product labelling issues.
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…Please note this is a Class 2 Patient, Pharmacy and Wholesaler level recall.
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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the Patient Information Leaflet (PIL) in the cartons for the batches listed in this notification were released with an outdated PIL.
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Medicines have been taken out of the regulated medicines’ supply chain during distribution. The products have been parallel imported into the UK by B & S Healthcare from Italy and have been re-labelled in B & S Healt…
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FDC Pharma are recalling batch 087B087 due to an out of specification result for an unknown impurity during stability testing. (EL(18)A/08)
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Glaxo Wellcome UK is recalling two Lots of Ventolin Accuhaler 200mcg because a manufacturing issue with these Lots has been identified which has resulted in a small number of units not delivering the full number of doses (EL…
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Sanofi has informed us that there is an error in the Braille on some batches of Arava 10mg film-coated tablets (EL (17)A/01)
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Martindale Pharmaceuticals Limited is recalling the above batch due to an issue with homogeneity.
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Winthrop Pharmaceuticals UK Limited (trading as Zentiva) is conducting a precautionary recall of a single batch of Molipaxin 100 mg capsules due to a potential issue with the metal detector during manufacture of the batch (E…
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Strides Pharma UK Ltd, trading as Co-pharma, is recalling specific batches of Diclo-SR 75 Tablets as a precautionary measure
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Ecolab are recalling batches of Klerpack BD Syringe Multi-Pack as the sterile packaging may contain small holes in the film of the pouch. (EL (16)A/13)
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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.
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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.
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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.
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Accord Healthcare Limited has informed us that there is an error on the portion of the Patient
Information Leaflet (PIL) for the Paracetamol Infusion which is intended for Healthcare Professionals.
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G Pharma Ltd have informed the MHRA that there is an error in the spelling of the active ingredient included on the imported carton. The spelling should be ‘Ticagrelor’ but has been printed as ‘Tricagelor’ under the brand na…
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Bayer Plc is recalling all stock of the products listed in this notification as a precautionary measure due to the identification of an impurity above the acceptable limit. The recall is at pharmacy and wholesaler level.
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Crescent Pharma Limited is recalling one batch of Ramipril 10mg Capsules as a precautionary measure due to a potential error at the manufacturing site.
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Action within 48 hours: B&S Healthcare are recalling two batches of parallel imported Medikinet XL 20mg modified-release capsules that have been incorrectly repackaged in 30mg cartons. (EL (16)A/08)
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Bayer plc and GE Healthcare AS are recalling batches of Magnevist Solution for injection, 0.5mmol/ml, intravenous and Omniscan Solutions for injection 0.5 mmol/ml following a safety review of the gadolinium containing contra…
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Dr. Reddy's Laboratories (UK) Ltd is recalling the above batch due to the potential for small particles of Aripiprazole active material to be present which may affect the efficacy of the product.
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Rosemont Pharmaceuticals Limited is recalling unexpired stock from pharmacies as a precautionary measure due to possible contamination with an impurity.
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Crescent Pharma Limited is recalling one batch of Ramipril 5 mg Capsules as a precautionary measure due to a potential error at the manufacturing site.
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Genesis Pharmaceuticals Ltd has informed us that there is an error on the Braille for the above batches which means that the strength reads as 1mg instead of 5mg. The printed text is correct on all packaging.
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Caution in Use: Distribute to Pharmacy, Hospital, GP, Dental Practice, Ward and Clinic Level.
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Caution in Use - Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level. (EL (18) A/05)
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Rosemont Pharmaceuticals Limited is recalling a single batch of Urospir 50mg/5ml Oral Solution (spironolactone) as a precautionary measure. The recall is due to errors in some of the dose calculation in millilitres being sta…
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Chemidex Pharma Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in their topical steroid products does not contain all the required safety information. Cartons for the products/batches listed are missing…
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Teva UK Limited has informed the MHRA that it plans to withdraw from further sale all batches of GoResp Digihaler (budesonide and formoterol fumarate dihydrate) and the linked Digihaler App for commercial reasons.
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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.
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Intrapharm Laboratories Ltd has informed us that they have received complaints that the consistency of a batch of Kolanticon Gel 500ml is lumpy. An investigation and retained samples for this batch show the same homogeneity …
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Reports that rubber stopper may be pushed into vial during reconstitution, rendering the vial unusable. (EL (16)A/11)
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Tillomed Laboratories Limited is recalling one batch of Labetalol 200mg Tablets as a precautionary measure due to potential mix-up at the manufacturing site.
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Relonchem Ltd has informed the MHRA that duplicate GTIN numbers have been assigned to certain Losartan potassium/Hydrochlorothiazide coated tablets in error and a duplicate EAN number has been assigned to certain Risperidone…
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Sanofi is recalling batches of product as a precautionary measure due to out of specification results for disintegration test during routine stability testing.
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Uni Health Distribution Ltd has informed the MHRA of a typographical error on the approved carton overlabel for certain batches of Utrogestan Vaginal 200 mg Capsules. The carton label references ‘micrograms’ where it should …
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Advanz Pharma is recalling batches of carbimazole tablets due to an out of specification observation for tablet appearance of samples during routine stability testing.
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Chelonia Healthcare Limited is recalling specific batches of Paracetamol 500mg Tablets (100 pots) as a precautionary measure due to contamination following a small number of complaints of discoloured tablets within the pots.
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Zambon SpA is recalling an affected batch as a precautionary measure due to out of specification results for unknown impurities during ongoing stability testing.
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Teva UK Limited is recalling one batch of Levothyroxine 12.5mcg Tablets in response to a lower than required assay result discovered during routine stability testing.
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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).
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Novartis Pharmaceuticals UK are recalling a batch of Sandimmun Oral Solution due to the presence of crystals in the solution.
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Aspar Pharmaceuticals Limited have informed the MHRA of an error related to a batch of Boots Paracetamol 500 mg tablets (16s). The foil blister inside the carton incorrectly states ‘Aspirin 300 mg Dispersible Tablets’. The t…
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Teva UK Limited is reporting a minor typographical error on the carton for Lansoprazole Gastro-Resistant Hard Capsules 15mg. There are two instances where the dosage form is stated as “tablets” where it should state “gastro…
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SyriMed are recalling the below batch as a precautionary measure due to an issue related to the container closure (child-lock cap).