All UK Class 4 medicine recalls recalls and safety alerts, newest first, with the hazard, affected models and what to do next. 197 listed.
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MHRA that the Patient Information Leaflet (PIL) packaged in certain batches of Zestoretic 20mg/12.5mg Tablets contains outdated safety information.
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.
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.
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informed the MHRA that the Patient Information Leaflet (PIL) packaged in some batches of Epiduo 0.1% / 2.5% gel contain outdated safety information regarding pregnancy.
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
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).
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.
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.
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).
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.
Recordati Rare Diseases T/A Recordati Rare Diseases UK Ltd has made the MHRA aware that specific batches of Pedea 5 mg/ml solution for injection have been packaged with the incorrect Product Information Leaflet (PIL).
Flamingo Pharma UK Ltd has identified an error relating to the ink printing of the batch number and expiry date on the carton for three batches of Ibuprofen 400mg Tablets. This notification includes all…
Rosemont Pharmaceuticals Ltd. has made the MHRA aware that the expiry dates stamped on the base of the bottle are incorrect for 2 batches of Atorvastatin 4mg/ml Oral Suspension and 2 batches of Sildenafil…
Quadrant Pharmaceuticals Limited have informed the MHRA of an error with the Patient Information Leaflets (PILs) that have been packaged in various parallel imported batches.
Accord Healthcare have informed us of an error with the patient information leaflets (PILs) that have been packaged in some Rosuvastatin products.
Novo Nordisk Limited would like to notify you of a defect that affects specific batches of NovoRapid FlexTouch prefilled pen device and batches of Saxenda FlexTouch prefilled pen device in the UK.
Omega Pharma Limited have identified an error relating to the product packaging.
Thornton & Ross have identified that the product labelling for some batches of ‘Pharmacy’ medicines do not contain the ‘P’ symbol, due to a packaging error on the bottle.
Altan Pharma Limited have identified an error relating to the product packaging. The incorrect concentration of phenylephrine base is provided on the overwrapping bag label.
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.
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.
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…
GlaxoSmithKline UK Ltd have informed the MHRA that an incorrect version of the Summary of Product Characteristics section 4.2 and the Patient Information Leaflet is inside the sealed pack, and contains unapproved text.
Pfizer Limited have informed the MHRA that an outdated version of the Patient Information Leaflet (PIL) has been included in the packaging of the specific batches mentioned in this notification.