-
The MHRA has been made aware that falsified medical oxygen has been provided to several dental practices across the UK.
-
Drugsrus Limited has informed the MHRA that a small number of bottles of Metronidazole 200 mg/5 ml Oral Suspension 100ml are leaking from the cap.
-
Orifarm UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in one batch of Buccolam 10mg Oromucosal solution has missing information regarding having to break the seal on the inner container before use.
-
Novartis Pharmaceuticals has informed the MHRA that the solvent (water for injections in ampoules) co-packed with the impacted batches of Simulect powder for injection, may contain glass fragments approximately 20 – 800 µm i…
-
Hikma Farmacêutica Portugal S.A has informed the MHRA of a potential issue impacting the batches listed in this notification.
-
Pharmaswiss Česka republika s.r.o. is initiating an urgent recall of all batches of Emerade 500 micrograms and Emerade 300 micrograms auto-injectors.
-
Omega Pharma Ltd has identified that there is text missing in Section 2 of the Patient Information Leaflet (PIL) in packs of Beconase Hayfever Nasal Spray (P).
-
Sandoz limited has informed the MHRA that the products mentioned in this notification are not sugar free despite the carton stating ‘sugar free’. The ‘sugar free’ text was added to the carton in December 2008 in error.
-
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 prod…
-
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.
-
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…
-
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.
-
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 represent…
-
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.
-
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.
-
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 (P…
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
List of Field Safety Notices (FSNs) from 21 to 25 November 2022
-
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.
-
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.
-
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 (PI…
-
Sanofi UK is initiating an urgent recall of two batches of Targocid 200mg powder for solution for injection/infusion or oral solution
-
hameln pharma ltd is initiating a recall of the affected batches of Ephedrine Hydrochloride 30 mg/ml Solution for Injection as a precautionary measure.
-
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 potentially impacted …
-
Sanofi is recalling all batches of Stemetil 5mg/5ml Syrup as a precautionary measure due to the identification of N-nitrosomethylphenylamine (NMPA) above the acceptable limit.
-
Novartis Pharmaceuticals UK are recalling a batch of Sandimmun Oral Solution due to the presence of crystals in the solution.
-
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 10mg/ml O…
-
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.
-
Hikma Pharmaceuticals USA Inc are recalling the below batches due to an out of specification result with related substances during testing for retain samples.
-
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.
-
Accord Healthcare have informed us of an error with the patient information leaflets (PILs) that have been packaged in some Rosuvastatin products.
-
Sun Pharmaceuticals are recalling batches of zoledronic acid due to out of specification results observed for Particulate Matter Test during routine stability testing.
-
Stockport Pharmaceuticals are recalling a batch of Sodium Chloride Eye Drops 5% w/v as the sterile eye droppers supplied with the medicinal product have expired (January 2022).
-
Clinigen Healthcare Ltd is initiating a recall of three batches of Mexiletine hydrochloride hard capsules due to a potential risk of underdose or overdose, which could have consequences for the safety of patients.
-
A.Vogel Ltd is recalling a specific batch of Pharmacy only medicine due to a small number of packs that were inadvertently supplied to non-pharmacy retail outlets.
-
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.