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List of Field Safety Notices (FSNs) from 27 to 31 March 2023.
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Ethigen Limited have informed the MHRA that the Patient Information Leaflet (PIL) in Briviact 75mg and Briviact 100mg film coated tablets contains incorrect or missing information.
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List of Field Safety Notices (FSNs) from 20 to 24 March 2023
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Ferring Pharmaceuticals Limited is recalling certain batches of GONAPEPTYL Depot 3.75mg due to a defect noticed in the seal of the needle wrapping for the CE-marked 30-millimeter (30mm) needle for subcutaneous injection that…
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List of Field Safety Notices (FSNs) from 13 to 17 March 2023
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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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List of Field Safety Notices (FSNs) from 6 to 10 March 2023
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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…
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Following the conclusion of a review of post-marketing safety data by the MHRA, all pholcodine-containing medicines are being recalled and withdrawn from the UK as a precaution.
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Drugsrus Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in specific batches of Clexane 10,000IU (100mg)/1 ml Syringes contains a typographical error in the leaflet.
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Thornton & Ross Ltd has informed the MHRA that specific batches of Methadone 1mg/mL Oral Solution BP Sugar Free and Methadone Mixture 1mg/ml, have been packaged with the incorrect Product Information Leaflet (PIL).
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List of Field Safety Notices (FSNs) from 27 February to 3 March 2023.
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List of Field Safety Notices (FSNs) from 20 to 24 February 2023
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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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IPS Pharma is recalling specific batches of levothyroxine oral suspension from pharmacies and impacted patients due to the concentration of levothyroxine being greater than the amount stated on the label.
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Atnahs Pharma UK has informed the MHRA that the Patient Information Leaflet (PIL) packaged in certain batches of Zestoretic 20mg/12.5mg Tablets contains outdated safety information.
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Reckitt Benckiser Healthcare (UK) Limited has informed the MHRA that a typographical error has been identified on the end flap of the outer carton of some batches of Lemsip Max Cold & Flu Capsules.
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List of Field Safety Notices (FSNs) from 13 to 17 February 2023
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As a precautionary measure, following an MHRA assessment of currently available data on EO levels, alternative devices to the BD BodyGuard Microsets should be sought in users of 5kg bodyweight and below.
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The National Joint Registry (NJR) has identified that both the NexGen® Stemmed Option Tibial Components, when paired with either the Legacy® Posterior Stabilized (LPS) Flex Option Femoral or the LPS Flex Gender Solutions Fem…
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List of Field Safety Notices (FSNs) from 6 to 10 February 2023.
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List of Field Safety Notices (FSNs) from 30 January to 3 February 2023.
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The MHRA is aware of cases of increased intraocular pressure in patients recently implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses (IOLs), which are manufactured by NIDEK and distribute…
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Carnamedica has identified issues with third-party suppliers, which could result in microbiological contamination, particulate matter within the solution, and leakage of fluid.
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Field Safety Notices (FSNs) from 23 to 27 January 2023
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Field Safety Notices (FSNs) from 26 January 2023.
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The MHRA is aware of reports of increased intraocular pressure in patients recently implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses (IOLs).
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Prulab Pharma Limited is recalling a batch of Cloipidogrel Oral Solution 75mg in 5ml due to a discrepancy with the product labelling that could result in an incorrect volume to be administered to the patient.
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Dr Reddy’s Laboratories (UK) Limited is recalling two batches of Lacidipine 4 mg Film-Coated Tablets as a precautionary measure due to the presence of an unknown solvent-like odour.
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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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List of Field Safety Notices (FSNs) from 9 to 13 January 2023.
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Specific batches of the product are recalled as a precautionary measure due to validation tests demonstrating the leaching of filter additives that are above the acceptable limit.
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List of Field Safety Notices (FSNs) from 2 to 6 January 2023.
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Albireo AB has informed the MHRA that there is a typographical error with the text on the side panel of the bottle label for a specific batch of Bylvay 1200 micrograms Hard Capsules.
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List of Field Safety Notices (FSNs) from 26 to 30 December 2022.
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List of Field Safety Notices (FSNs) from 19 to 23 December 2022.
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Galderma (U.K.) Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in some batches of Epiduo 0.1% / 2.5% gel contain outdated safety information regarding pregnancy.
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Galderma (U.K.) Limited has informed the MHRA that the patient information leaflet (PIL) packaged in specific batches of Etrivex Shampoo is missing safety information
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List of Field Safety Notices (FSNs) from 28 November to 2 December 2022
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ADVANZ PHARMA has made the MHRA aware that certain batches of MacroBID 100mg Prolonged-Release Capsules have been packed with the incorrect Patient Information Leaflet (PIL).
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Lucis Pharma Ltd has informed the MHRA that there is a typographical error with text on the rear side of the outer packaging for Oxycodone Hydrochloride 10mg/ml Oral Solution.
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List of Field Safety Notices (FSNs) from 21 to 25 November 2022
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List of Field Safety Notices (FSNs) from 14 to 18 November 2022
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Morningside Healthcare Limited has informed the MHRA of an error with the Patient Information Leaflet (PIL) packaged in batch 22237001 of Hyoscine Butylbromide 20 mg Film-coated Tablets.
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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 300 mg prolonged-release tablets).
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List of Field Safety Notices (FSNs) from 7 to 11 November 2022
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Macarthys Laboratories (trading as Martindale Pharma, an Ethypharm Group Company), has notified the MHRA of a limited number of Prenoxad packs in a batch marketed in France with missing needles.
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List of Field Safety Notices (FSNs) from 31 October to 4 November 2022
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List of Field Safety Notices (FSNs) from 24 to 28 October 2022
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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.