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The UK Marketing Authorisation Holder has confirmed that a batch of Dysport 500 Units Powder for Solution for Injection is falsified and has been supplied by unauthorised distributors to the UK.
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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.
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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).
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Dr Reddy’s Laboratories (UK) Limited is recalling all unexpired stock of a specific batch of Nitrofurantoin 50mg Tablets from pharmacies and wholesalers as a precautionary measure due to out of specification results for diss…
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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 Pfizer Limited has informed the MHRA that the product is being withdrawn due to emerging data from clinical trials and registry-based studies.
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Jubilant Pharmaceuticals NV has informed the MHRA that the Patient information leaflet (PIL) in the cartons for the batches listed is outdated.
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Galderma UK identified an error regarding an older version of artwork being used and packed with specific batches of Tetralysal 300mg Hard Capsules.
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Thame Laboratories are recalling the above batches due to an issue with the container closure (child-resistant cap).
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Accord Healthcare Ltd has informed us that when decommissioning at the pharmacy and scanning the serialised 2D code, the status of certain packs may report as ‘EXPORT.’
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Action within 48 hours: Glaxo Wellcome UK Ltd is recalling 4 batches of Respontin Nebules due to out of specification results for impurities obtained during routine stability testing (EL (16)A/10)
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Crescent Pharma Limited has informed the MHRA of an error with the European Article Number (EAN) barcode on the cartons of a batch of simvastatin 10 mg Tablets distributed by Alliance Healthcare UK.
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Pfizer Limited has informed us that the text on the carton label for the above product has recently been updated and at this time, the product description on the carton was changed from 10 x 1ml ampoules to 10 x 2ml ampoules…
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Crescent Pharma Ltd has informed us of a discrepancy on the product packaging.
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hameln pharma ltd are recalling batches of product additional to the batch recalled on 15 February 2022 (reference EL(22)A/06).
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TEVA UK Limited has informed us that the Product Code/GTIN (PC) number found on the below batches is incorrect.
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Tillomed Laboratories Limited is recalling one batch of Labetalol 200mg Tablets due to an error on the foil blister packaging.
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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.
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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.
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Caution in Use: Distribute to Pharmacy and Clinic Level.
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Orifarm UK have informed us of an error with the Patient Information Leaflet (PIL) packaged within the packs of certain batches. The product name stated in the heading of the PIL has been spelt incorrectly as “lorazolam”, in…
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Some valsartan containing products including certain batches supplied by Teva UK Limited and all unexpired batches supplied by Mylan are being recalled.
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UCB Pharma Ltd is recalling one batch of Dioctyl 100 mg Capsules as a precautionary measure due to the presence of a foreign capsule being found in a sealed pack.
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Bristol Laboratories Limited are recalling a batch of this product as a precautionary measure due to low dissolution test results reported during ongoing stability studies.
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Aspen Pharma Trading Limited is recalling a specific batch of Mercaptopurine 50mg tablets as a precautionary measure due to microbial contamination following a small number of complaints of discoloured tablets within the pac…
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Action Within 48 Hours. Wholesaler and Pharmacy Level Recall. Teva UK Limited is recalling batches due to out of specification results for impurities obtained during routine stability testing.
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BCM Specials Limited is recalling a specific batch of Mepacrine Hydroxychloride 100 mg tablets due to a number of foreign body particulates found in the containers of the API used to make it.
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Intrapharm Laboratories Ltd has informed us that there is a difference in dosage instructions between the carton and label. The Patient Information Leaflet (PIL) and bottle label contain the correct instructions.
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DEMO SA PHARMACEUTICAL INDUSTRY has informed us that the Product Code/GTIN (PC) number found on the above batch is incorrect. The GTIN number that should have been allocated for this batch is 5200040321010.
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Alliance Pharmaceuticals Ltd has informed the MHRA that there are possible side effects not reported on the Patient Information Leaflet.
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Torrent Pharma (UK) Limited is recalling certain batches of Ramipril 1.25mg tablets as a precautionary measure due to these batches having a low assay and high related substances test results after their release to the marke…
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Martindale Pharma has informed the Medicines and Healthcare products Regulatory Agency (MHRA) that the EAN bar code for the following batches is incorrect.
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Napp Pharmaceuticals Limited have identified an error relating to the Braille printed on the cartons. The
Braille message on the Oxycontin 20mg prolonged release tablets incorrectly states strength as 15mg.
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Lexon UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the cartons for the batches listed in this notification is missing important updated safety information.
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Exeltis UK Limited has informed the MHRA regarding an inconsistency in the Patient Information Leaflet (PIL) packaged in cartons of the specified batches of Gepretix 100mg capsules.
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Medicines from the listed parallel distributors are being recalled due to concerns that the supply chain may have been compromised and the origins of the products are unknown
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B. Braun Medical Limited is recalling various product batches as a precautionary measure after traces of midazolam were detected in the batches listed in this notification.
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Fresenius Kabi Limited have identified an error on the infusion bag packaged in certain batches.
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Wockhardt UK Ltd are recalling a batch of Diazepam RecTubes 2.5mg Rectal Solution due to an out of specification result for assay during routine stability testing.
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Intrapharm Laboratories Ltd are recalling the above batch of Mydrilate 0.5 % Eye Drops 5ml as a precautionary measure due to out of specification results for related substances obtained during stability testing.
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Ipca Laboratories UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the products listed in this notification do not contain all the required safety information.
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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.
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Accord Healthcare Ltd has informed us that the Patient Information Leaflet (PIL) for all strengths of Atrolak XL Prolonged-release tablets is missing the side effects identified from post-marketing experience.
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Kyowa Kirin Limited is recalling a specific batch as a precautionary measure, due to the reports of double tablets in a single blister pocket. This was identified during reference sample inspection and there is a potential l…
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Kent Pharma UK has identified an error in the Patient Information Leaflet (PIL) for Paracetamol 500mg Effervescent Tablets.
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Drugsrus Ltd (distributor) / Tenolol Ltd (MA Holder) has informed us of a typographical error in active ingredient stated on the label on the vial.
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Wockhardt UK Limited is recalling a batch as a precautionary measure following the identification of a dissolution failure during stability testing.
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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…
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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 dissolution during routine product release testing.
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Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerade 150 microgram auto-injectors (also referred to as pens) from patients due to an error in one com…
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Aspar Pharmaceuticals Ltd is recalling specific batches distributed in Aspar, Almus and Numark livery. The batches are being recalled as a precautionary measure following findings of foil perforations in some blisters.