tag:www.gov.uk,2005:/drug-device-alerts 2025-04-02T14:01:02+01:00 HM Government tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-urospir-50mg-slash-5ml-oral-solution-el-25-a-slash-14 2025-04-02T14:01:02+01:00

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�

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-utrogestan-vaginal-200-mg-capsules-progesterone-el-25-a-slash-13 2025-04-01T10:58:54+01:00

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 �

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-notification-sirdupla-25-microgram-slash-250-microgram-per-metered-dose-pressurised-inhalation-suspension-el-25-a-slash-12 2025-03-31T11:04:37+01:00

Cross Healthcare Limited have informed the MHRA that there is a printing defect on the outer labels for the Sirdupla 25 microgram/250 microgram per metered dose pressurised inhalation, suspension, batch 77518.

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-notification-azithromycin-250-mg-capsules-el-25-a-slash-11 2025-03-12T15:28:41+00:00

Jubilant Pharmaceuticals NV has informed the MHRA that the Patient information leaflet (PIL) in the cartons for the batches listed is outdated.

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-boots-paracetamol-500-mg-tablets-16s-el-25-a-slash-10 2025-03-04T14:35:01+00:00

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�

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-sun-pharmaceutical-industries-europe-b-dot-v-pemetrexed-1000mg-slash-100ml-10mg-slash-ml-and-800mg-slash-ml-8mg-slash-ml-infusion-bag-el-25-a-slash-09 2025-03-04T11:02:39+00:00

Sun Pharmaceutical Industries Europe B.V. is recalling those product batches listed in this notification as a precautionary measure due to out of specification results reported for the Particulate Matter Test (PMT) during st�

tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-azacitidine-100-mg-slash-vial-and-150-mg-slash-vial-powder-for-suspension-for-injection-el-25-a-slash-08 2025-03-03T11:03:15+00:00

Accord Healthcare Limited is recalling certain batches of Azacitidine Powder for Suspension for Injection 100 mg/vial and 150 mg/vial as precautionary measure due to out of specification results for Azacitidine related compo�

tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-glucophage-sr-500-mg-750mg-and-1000mg-prolonged-release-tablets-el-25-a-slash-07 2025-02-20T14:00:20+00:00

All batches of the named products are being recalled by the Marketing Authorisation Holder in Italy and subsequent UK parallel distributor companies as a precautionary measure due to the product being manufactured with the i�

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-notification-lansoprazole-gastro-resistant-hard-capsules-15mg-el-25-a-slash-06 2025-02-11T11:00:20+00:00

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�

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-nitrofurantoin-cnx-therapeutics-100-mg-prolonged-release-capsules-el-25-a-slash-05 2025-02-05T10:00:55+00:00

CNX Therapeutics is recalling the batches listed in this notification as a precautionary measure due to a small number of packs that contain an additional tablet of Nitrofurantoin. The registered product is a capsule contain�

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-bristol-laboratories-limited-amlodipine-bristol-lab-2-dot-5-mg-tablets-el-25-a-slash-04 2025-01-30T11:00:10+00:00

Bristol Laboratories Limited is recalling the batches specified in the table as a precautionary measure due to possible microbial contamination.

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-tesco-health-dry-cough-relief-200ml-asda-strong-dry-tickly-cough-200ml-almus-dry-cough-relief-and-bells-dual-action-dry-cough-el-25-a-slash-03 2025-01-22T13:07:22+00:00

Bells Healthcare is recalling the listed batches of dextromethorphan hydrobromide BP containing products as a precautionary measure, due to foreign material detected in some bottles.

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-notification-irbesartan-150-mg-and-300-mg-film-coated-tablets-el-25-a-slash-02 2025-01-13T11:01:21+00:00

Jubilant Pharmaceuticals NV has informed the MHRA that the Patient information leaflet (PIL) in the cartons for the batches listed in this notification include an outdated PIL.

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-notification-rabeprazole-sodium-10mg-and-20mg-gastro-resistant-tablets-el-25-a-slash-01 2025-01-09T11:10:43+00:00

Bristol Laboratories Limited has informed the MHRA that the Patient Information Leaflet (PIL) in the batches in the table for Rabeprazole sodium 10mg and 20mg gastro-resistant tablets do not contain the most up to date safet�

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-notification-argenx-bv-vyvgart-1000-mg-solution-for-injection-el-24-a-slash-63 2024-12-19T11:06:52+00:00

Argenx BV have informed MHRA that the Patient Information Leaflet (PIL) in the affected packs incorrectly contains reference to two subcutaneous injection sites. Only subcutaneous injection to the abdomen is permitted.

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-wockhardt-uk-limited-wockair-160-microgram-slash-4-dot-5-microgram-inhalation-powder-el-24-a-slash-62 2024-12-09T11:03:55+00:00

Wockhardt UK Limited is recalling this batch as a precautionary measure following the identification of a low number of units which may have a defect in the 'top case' resulting in a dose not being able to be dispens�

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-brillpharma-limited-oxybutynin-hydrochloride-brillpharma-2-dot-5-mg-slash-5-ml-oral-solution-el-24-a-slash-61 2024-12-04T11:01:02+00:00

L M Manufacturing Limited has informed the MHRA that the patient information leaflet (PIL) in the cartons for the batch listed for Oxybutynin hydrochloride Brillpharma 2.5 mg/5 ml Oral Solution include an out of date PIL, da�

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-kent-pharma-uk-phenoxymethylpenicillin-250mg-slash-5ml-oral-solution-sugar-free-el-24-a-slash-60 2024-12-03T14:17:57+00:00

Kent Pharma UK is recalling a batch of phenoxymethylpenicillin 250mg/5mL oral solution sugar free due to a low phenoxymethylpenicillin assay.

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-rosemont-pharmaceuticals-limited-mycophenolate-mofetil-1g-slash-5ml-oral-suspension-el-24-a-slash-59 2024-12-02T14:00:03+00:00

Rosemont Pharmaceuticals Limited has informed the MHRA that the Press-In-Bottle-Adaptor (PIBA) supplied with the batches listed above may cause the medicine to leak when attempting to withdraw a dose.

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-strides-pharma-uk-ltd-liothyronine-sodium-5-and-20-micrograms-tablets-el-24-a-slash-58 2024-11-28T11:07:36+00:00

Strides Pharma UK Ltd has informed MHRA of an error in the patient information leaflet (PIL) for Liothyronine Sodium 20 micrograms Tablets and Liothyronine Sodium 5 micrograms Tablets.

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-morningside-healthcare-limited-tramadol-hydrochloride-50-mg-capsules-and-tramadol-hydrochloride-morningside-50-mg-prolonged-release-capsules-el-24-a-slash-57 2024-11-27T13:59:23+00:00

Morningside Healthcare Limited has informed the MHRA of a packaging issue identified in batch MRA2303 of Tramadol Hydrochloride Morningside 50 mg Prolonged-Release Capsules and batch MRF2301 of Tramadol Hydrochloride 50 mg C�

tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-syri-limited-t-slash-a-syrimed-baclofen-10mg-slash-5ml-oral-solution-el-24-a-slash-56 2024-11-25T14:01:22+00:00

Syri Limited, T/A SyriMed is recalling this batch of product as a precautionary measure due to crystallisation observed over time in the oral solution.

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-takeda-uk-limited-entyvio-108mg-solution-for-injection-in-pre-filled-syringe-el-24-a-slash-55 2024-11-18T14:24:41+00:00

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.

tag:www.gov.uk,2005:/drug-device-alerts/company-led-medicines-recall-leeds-trading-company-ltc-ltd-t-slash-a-ltc-healthcare-exs-delay-spray-plus-clmr-24-a-slash-01 2024-11-13T14:15:19+00:00

LTC Healthcare has informed the MHRA that they have been selling a medicinal product containing lidocaine without authorisation from the MHRA.

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-viatris-uk-healthcare-ltd-omeprazole-40-mg-powder-for-solution-for-infusion-el-24-a-slash-54 2024-11-12T10:59:54+00:00

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 not contain the most up to date safety information.

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-ennogen-healthcare-limited-zoledronic-acid-ennogen-4mg-slash-5ml-concentrate-for-solution-for-infusion-el-24-a-slash-53 2024-11-07T13:59:45+00:00

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 of the approved Additional Risk Minimisation Measures �

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-tillomed-laboratories-limited-labetalol-200mg-tablets-el-24-a-slash-52 2024-10-31T11:15:50+00:00

Tillomed Laboratories Limited is recalling one batch of Labetalol 200mg Tablets as a precautionary measure due to potential mix-up at the manufacturing site.

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-kent-pharma-uk-parasolve-paracetamol-500mg-effervescent-tablets-el-24-a-slash-51 2024-10-28T10:59:40+00:00

Kent Pharma UK has identified an error in the Patient Information Leaflet (PIL) for Paracetamol 500mg Effervescent Tablets.

tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-glenmark-pharmaceuticals-europe-ltd-cyanocobalamin-50-mcg-tablets-el-24-a-slash-46 2024-10-24T10:02:15+01:00

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 additional re-testing.

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-bristol-laboratories-ltd-phenobarbital-bristol-labs-15mg-tablets-el-24-a-slash-50 2024-10-23T10:59:59+01:00

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 within the tablets.

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-kent-pharma-uk-paracetamol-500mg-effervescent-tablets-el-24-a-slash-49 2024-10-21T11:02:21+01:00

Kent Pharma UK has identified an error in the Patient Information Leaflet (PIL) for Paracetamol 500mg Effervescent Tablets.

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-sandoz-ltd-dot-linezolid-600-mg-film-coated-tablets-el-24-a-slash-48 2024-10-10T10:58:08+01:00

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 mg film-coated tablets.

tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-viatris-uk-healthcare-ltd-trandolapril-2mg-and-4mg-capsules-el-24-a-slash-47 2024-10-07T11:00:17+01:00

Generics (UK) Ltd T/A Mylan UK is recalling specific batches of trandolapril after re-testing showed out of specification results.

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-sandoz-ltd-dot-rosuvastatin-20mg-40mg-tablets-el-24-a-slash-45 2024-10-01T11:00:44+01:00

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 Rosuvastatin 20mg and 40mg Tablets.

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-pfizer-limited-oxbryta-500mg-tablets-voxelotor-el-24-a-slash-44 2024-09-30T13:15:15+01:00

Pfizer Limited is recalling all distributed batches of Oxbryta 500 mg Tablets. Pfizer Limited has informed the MHRA that the product is being withdrawn due to emerging data from clinical trials and registry-based studies.

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-sandoz-ltd-dot-risperidone-1mg-2mg-3mg-tablets-el-24-a-slash-43 2024-09-26T13:03:12+01:00

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 Risperidone 1mg, 2mg and 3mg and Tablets.

tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-orion-pharma-uk-ltd-eldepryl-5mg-tablets-selegiline-el-24-a-slash-42 2024-09-18T11:27:37+01:00

Orion Pharma (UK) Ltd is recalling this batch as a precautionary measure due to an out of specification result in the assay result during the follow up stability study of the batch.

tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-theramex-hq-uk-ltd-evorel-sequi-el-24-a-slash-41 2024-09-12T11:01:33+01:00

Theramex has informed the MHRA that some cartons of Evorel Sequi contain the incorrect combination of patches. An error at the packaging site means that a limited number of packs have the incorrect combination of Evorel 50 a�

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-chemidex-pharma-ltd-ponstan-250mg-capsules-and-500mg-tablets-mefenamic-acid-el-24-a-slash-40 2024-08-27T11:09:32+01:00

Chemidex pharma ltd has informed the MHRA that the patient information leaflet (PIL) in the cartons for the batches listed in the tables for Ponstan 250mg capsules and Ponstan Forte 500mg tablets include an out of date PIL, �

tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-glenmark-pharmaceuticals-europe-ltd-fingolimod-0-dot-5-mg-hard-capsules-el-24-a-slash-39 2024-08-19T11:05:05+01:00

Glenmark Pharmaceuticals Europe Ltd is recalling this batch after retesting showed out of specification results.

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-strides-pharma-uk-limited-loperamide-hydrochloride-capsules-2mg-el-24-a-slash-38 2024-08-15T10:59:22+01:00

Strides Pharma UK Ltd is recalling the listed batch as a precautionary measure due to an out of specification result for microbial contamination, reported during retesting.

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-dawa-limited-trazodone-hydrochloride-50mg-100mg-capsules-and-50mg-slash-5ml-oral-solution-el-24-a-slash-37 2024-08-14T11:01:13+01:00

Dawa Limited has informed the MHRA of an error with the Patient Information Leaflets (PILs) that have been packed in the listed batches of Trazodone Hydrochloride 50mg and 100mg Capsules and Trazodone Hydrochloride 50mg/5ml �

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-notification-star-pharmaceuticals-limited-diflucan-oral-suspension-40mg-slash-ml-el-24-a36 2024-08-12T11:00:14+01:00

Star Pharmaceuticals Limited has informed the MHRA that an error has been identified in the Patient Information Leaflet (PIL) for two batches of Diflucan Oral Suspension 40mg/ml.

tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-accord-uk-ltd-trandolapril-0-dot-5mg-2mg-4mg-capsules-el-24-a-slash-35 2024-08-08T10:58:27+01:00

Accord-UK Ltd is recalling the listed batches after retesting showed out of specification results.

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-sandoz-limited-omeprazole-products-el-24-a-slash-34 2024-08-07T10:02:56+01:00

Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPCs) of the specific products listed in this notification.

tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-glenmark-pharmaceuticals-europe-ltd-atomoxetine-10mg-18mg-25mg-10mg-40mg-60mg-80mg-and-100mg-hard-capsules-el-24-a-slash-33 2024-07-30T10:00:08+01:00

Glenmark Pharmaceuticals Europe Ltd is recalling various batches after retesting showed out of specification results.

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-aspen-pharma-trading-limited-co-trimoxazole-80mg-slash-400mg-per-5ml-adult-suspension-el-24-a-slash-32 2024-07-25T13:59:24+01:00

Aspen Pharma Trading Limited has informed the MHRA that an error has been found in the Patient Information Leaflet.

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-fresenius-kabi-limited-hartmanns-solution-for-injection-bp-as-steriflex-no-11-or-freeflex-el-24-a-slash-31 2024-07-24T11:02:21+01:00

Fresenius Kabi Limited has informed the MHRA of a labelling error on the packaging of Hartmann’s solution for Injection BP as Steriflex No.11 or freeflex.

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-glaxo-wellcome-uk-limited-trading-as-glaxosmithkline-uk-flolan-1-dot-5-mg-powder-and-solvent-for-solution-for-infusion-el-24-a-slash-30 2024-07-22T15:01:01+01:00

Glaxo Wellcome UK Ltd (GSK) has informed the MHRA that vials of Flolan 1.5 mg Powder and Solvent for Solution for Infusion, batch number AB8M may have been damaged during the packaging process.

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-sun-pharma-uk-limited-pemetrexed-1000mg-slash-100ml-10mg-slash-ml-and-1100mg-slash-100ml-11mg-slash-ml-infusion-bag-el-24-a-slash-29 2024-07-16T11:07:38+01:00

Sun Pharmaceutical Industries Europe B.V. is recalling the listed batches as a precautionary measure due to visible particulate matter during stability testing.