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Medley Pharma Limited is recalling all unexpired stock of the below products from pharmacies and retail stores as a precautionary measure.…
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Medreich Plc is recalling all unexpired stock of the above products from pharmacies and wholesalers as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.
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Accord-UK Limited is recalling all unexpired stock of Gliclazide 40 mg Tablets (Northstar Livery) from pharmacies and wholesalers as a precautionary measure due to out of specification results for dissolution, obtained during routine stability testing.
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…SANTEN Oy (trading as Santen UK Limited) are recalling the above batches of products as a precautionary measure due to detection of particles/crystals of the active pharmaceutical ingredient ciclosporin.…
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…LEO Laboratories Ltd (T/A LEO Pharma) is recalling all unexpired stock of the above products from pharmacies and wholesalers as a precautionary measure due to concerns on the possible risk of skin malignancy.…
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Mylan UK Healthcare Ltd is recalling remaining stock of certain batches as a precautionary measure after a product sterility non-compliance event which occurred during a recent inspection at the contract manufacturing site.
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…Qualasept Ltd t/a Bath ASU is recalling a specific batch of Irinotecan 200mg/260mL in sodium chloride 0.9% w/v intravenous infusion and specific batches of Infliximab (Remsima) Intravenous infusion in Sodium Chloride 0.9%w/v due to risks of reduced product quality.…
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…Losartan Potassium containing products from Accord Healthcare Limited are affected and the batches listed above are being recalled.
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Actavis Group PTC EHF is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA).
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(Teva UK Limited) red precipitate found during stability testing under cold storage conditions - class 2 action within 48 hours. (EL (14)A/13)
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Huddersfield Pharmacy Specials (HPS) is recalling the above batches of phosphates solution for infusion due to observation of precipitation in batch 500609X. The decision to recall all other batches has been made as a precautionary measure.
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Omega Pharma Limited and Galpharm International Limited are recalling unexpired stock from pharmacies and retail stores as a precautionary measure due to possible contamination with an impurity.
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(Teva UK and Numark liveries) Remaining stock should be returned to wholesaler for credit – class 3 action within 5 days. (EL (12)A/13)
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(Allergan UK Limited) Specific batch including a Danish language pack was shipped to the UK in error. Class 3 – action within 5 days. (EL (15)A/03)
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Britannia Pharmaceuticals Ltd has issued a company-led drug alert for Denzapine 50mg/ml Oral Suspension (CLDA (18)A/03)
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Ferring Pharmaceuticals Limited is recalling all unexpired stock of the products below from pharmacies and wholesalers as a precautionary measure due to a lower volume of solution being observed in the bottles, and out of specification results for the content of the desmopressin acetate…
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Class 2 Medicines Recall: Nutriflex Omega Plus 1250ml, 1875ml and 2500ml, PL 03551/0119, and Nutriflex Omega Special 625ml, 1250ml, 1875ml and 2500ml, PL 03551/0118 and Supplemented Product codes ASNSPOMCA, ASNSPOMSVA, ASNPLOMCA, ASNPLOMSVA (625ml, 1250ml, 1875ml 2500ml) (EL(19)A/31)
B Braun is initiating a recall of certain batches of the above products as a precautionary measure. This is because ongoing product monitoring has identified that some bags may not comply with the required specification throughout the product shelf-life.
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Rosemont Pharmaceuticals Limited, MS 427 is issuing a company-led drug alert for an unlicensed medicine Phenytoin 90mg/5ml Oral Suspension (CLDA (18)A/02).
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Takeda UK Ltd are issuing a company-led drug alert for one batch of Calcichew-D3 500mg/400 IU Caplets due to traces of a non-approved excipient (CLDA (17)A/05)
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Claris Lifesciences UK Limited are issuing a company-led drug alert for one batch of Mesna 100mg/ml solution for injection/infusion, 5 x 4ml due to stability issues (CLDA (18)A/01)
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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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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…
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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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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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GL Pharma is recalling a specific batch of Oxylan 40mg prolonged-release tablets due to out of specification results for dissolution during routine stability testing.
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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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The company has informed us that the consistency of the product within the batches has a reduced viscosity and more closely resembles a lotion than a cream.
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Recordati Pharmaceuticals Limited has informed the MHRA of an error in the strength of the product printed on some of the faces (sides) of the product carton. The error is limited to one batch of Lercanidipine HCl 20mg Table…
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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…
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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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Uni Health Distribution is aware of a potential issue where the leaflet contained within Efudix 5% w/w cream (2 x 20g) pack, batch 80193439/B may be incorrect.
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(Bayer plc) Remaining stock of affected batches should be quarantined for uplift by Bayer - class 3 action within 5 days (EL (17)A/03)
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Laboratoires Théa trading as Thea Pharmaceuticals Limited have notified the MHRA of an out of specification event related to environmental monitoring during manufacturing, which may increase the risk of microbial contaminati…
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Strandhaven Limited T/A Somex Pharma has informed the MHRA that the pack size on some cartons of the batch in this notification state 8 tablets instead of 4 tablets.
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Becton Dickinson UK Ltd has informed the MHRA that some units exhibit an open seal on the packaging of the applicator. This defect could increase the risk of the applicator device being contaminated with pathogens, which cou…
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Manufactured by Eurotrol B.V – may give readings below the values assigned to the product, leading to incorrect measurement results.
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The importer and distributor of the above products has informed us of reports that the microbial limit for Total Microbial Aerobic Count (TAMC) has been tested to exceed the predefined limit of 200 CfU/g as per the product s…
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LTC Healthcare has informed the MHRA that they have been selling a medicinal product containing lidocaine without authorisation from the MHRA.
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The MHRA has been made aware that falsified medical oxygen has been provided to several dental practices across the UK.
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Rosemont Pharmaceuticals Limited has informed the MHRA that the Press In Bottle Adaptor (PIBA) supplied with the pack (carton) of a specific batch is too wide to fit the neck of the medicine bottle.
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Becton Dickinson UK Ltd has informed the MHRA that some units exhibit an open seal on the packaging of the applicator. This is linked to the Class 2 Medicines Notification EL(25)A/22. This defect could increase the risk of …
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A batch of Depo-Medrone has been released to the market with an error. The vial over label incorrectly states that the total vial content is 40 mg in 1 mL, when the correct total vial content is 80mg in 2 mL (with a concentr…
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Kent Pharmaceuticals Ltd has informed us that several batches of finished product were contaminated with theophylline due to a cross-contamination issue identified with an excipient that was used in the manufacture of the fi…
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Chiesi Ltd has informed the MHRA about a potential issue with the batches listed in this notification. This is due to intermittent high results for the uniformity of delivered dose of formoterol fumarate observed during stab…
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The MHRA has become aware of Hysteroscopy Sheaths supplied in the UK market with a withdrawn CE certificate. Healthcare professionals and providers should immediately stop use, quarantine, and stop supply of any identified p…
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Pharmaram Ltd has informed us that a specific batch of Clexane 4,000IU (40mg)/0.4ml syringes has an error on the labelling affixed to the plastic blister packaging encasing the syringe.
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Sanofi is recalling batch number A9306 of the above product as a precautionary measure due to an out of specification result detected for Rasburicase enzyme activity according to a specific method and specifications for US market, at 12 months stability time point.
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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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Bristol-Myers Squibb Pharmaceuticals Limited has informed the MHRA that a potential product quality issue has been detected, relating to incomplete crimping of the metal crimp cap of OPDIVO 10mg/mL concentrate for solution f…
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Recalls of medicines issued by manufacturers.