Class 4 Medicines Defect Notification: Sandoz Limited, Apixaban 2.5mg and 5mg Tablets
Sandoz Ltd. have informed the MHRA that the Patient Information Leaflet included in specified batches of Apixaban does not contain up‑to‑date information.
Medicine recalls page 2
Medicine recalls, drug alerts and medical device warnings from the MHRA. 578 listed.
Class 4 Medicines Defect Notification: Quadrant Pharmaceuticals Limited, Vesomni 6 mg/0.4 mg modified release tablets
Quadrant Pharmaceuticals Limited have informed the MHRA that their parallel imported packs of Vesomni 6 mg/0.4 mg modified release tablets have been printed with the incorrect barcode/GTIN on the carton.
Regent Medical Limited / Mölnlycke Health Care, Hibiwash 500ml
Mölnlycke Health Care are recalling specific batches of Hibiwash due to microbial contamination at the manufacturing facility, following routine weekly microbiological monitoring.
Class 4 Medicines Defect Notification: Baxter Healthcare Corporation, Onkotrone Injection 2 mg/ml concentrate for solution for infusion
Baxter Healthcare Corporation have informed the MHRA that the Patient Information Leaflet (PIL) packed in specified batches does not contain up to date information relating to the duration of contraception required for females after…
Rokshaw Limited Trading as Curaleaf Laboratories, Curaleaf Oil [FS] 10mg/ml THC, 10mg/ml CBD (30ml)
Curaleaf Laboratories are recalling three batches of Curaleaf Oil [FS] 10mg/ml THC 10mg/ml CBD (30ml) due to low THC content.
Bayer Plc, Various Products
Bayer Plc is recalling all stock of the products listed in this notification as a precautionary measure due to the identification of an impurity above the acceptable limit. The recall is at pharmacy and…
Crescent Pharma Limited, Ramipril 5mg capsules
Crescent Pharma Limited is recalling one batch of Ramipril 5 mg Capsules as a precautionary measure due to a potential error at the manufacturing site.
Sterling Pharmaceuticals Ltd (specials manufacturer MS 32515), KidNaps (Melatonin) 1mg in 1ml Oral Solution
Sterling Pharmaceuticals Ltd and Veriton Pharma Ltd are recalling all batches of KidNaps (Melatonin) 1mg in 1ml Oral Solution due to out of specification stability results.
Norgine Limited, MOVICOL Ease Citrus Powder for oral solution 13.7 g
Norgine Limited is recalling one batch of product as a precautionary measure due to some units containing low amounts of active ingredients.
Aspar Pharmaceuticals Ltd, Ibuprofen 200mg Tablets, Ibucalm 200mg tablets
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.
Syri Limited, T/A SyriMed, Baclofen 10mg/5ml Oral Solution
Syri Limited, T/A SyriMed is recalling batches of product as a precautionary measure due to crystallisation observed over time in the oral solution.
Accord Healthcare Ltd, Carmustine 100 mg Powder and Solvent for Concentrate for Solution for Infusion (1 vial 100mg powder, 1 vial of 3 mL solvent)
Accord Healthcare limited is recalling a single batch due to an out of specification test result.
Class 4 Medicines Defect Notification: Viatris Products Ltd, Arixtra solution for injection, pre-filled syringes
Viatris has received reports of brown discolouration and blockage in the needle of pre-filled syringes of Arixtra. This quality defect is related to oxidation of the syringe needle.
Class 4 Medicines Defect Notification: Blumont Pharma Limited, Ocumont Eye Ointment 1% w/w
Blumont Pharma Limited is reporting to the MHRA regarding the absence of Braille on the outer carton of one batch of Ocumont Eye Ointment 1% w/w (POM). It was identified that the Braille information…
Glenmark Pharmaceuticals Europe Limited, Fingolimod Glenmark 0.5 mg Hard Capsules
Glenmark Pharmaceuticals Europe Limited is recalling one batch after stability testing showed out-of-specification results. The batch is being recalled as a precautionary measure following test results that showed a delay in capsule dissolution.
Mercury Pharmaceuticals Ltd, Paliperidone Mercury Pharma prolonged-release suspension for injection in pre-filled syringes
Mercury Pharmaceuticals Ltd is recalling remaining stock of paliperidone pre-filled syringes as a precautionary measure due to Good Manufacturing Practice (GMP) deficiencies cited during a recent inspection at the finished product manufacturing site.
Activase Pharmaceuticals Limited, Prednisolone 5mg Soluble Tablets
Activase Pharmaceuticals Limited is recalling two batches of Prednisolone 5mg Soluble Tablets as a precautionary measure due to a limited number of reports of blister pockets becoming swollen over time.
Hameln Pharma Ltd, Clarithromycin 500 mg powder for concentrate for solution for infusion
Hameln Pharma Ltd is recalling certain batches of Clarithromycin 500 mg powder for concentrate for solution for infusion.
Class 4 Medicines Defect Notification: Flamingo Pharma UK Ltd, Amitriptyline Hydrochloride 10mg, 25mg, 50mg Tablets
Flamingo Pharma 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.
Class 4 Medicines Defect Notification: Special Concept Development UK Limited, Baclofen 10mg Tablets
Special Concept Development UK Limited has informed the MHRA that the Patient Information Leaflet (PIL) for the batches listed in this notification do not contain the correct safety information.
Class 4 Medicines Defect Notification: Lexon UK Ltd, Moclobemide 150mg tablets
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.
Sun Pharmaceutical Industries Limited, Fingolimod SUN 0.5mg hard capsules
Sun Pharma UK Limited is conducting a precautionary recall of a single batch of Fingolimod SUN 0.5 mg hard capsules due to reports of capsule breakage on removing from the blister. No other batches…
Sun Pharmaceutical Industries Limited, Atorvastatin 20mg and 80mg Film-coated Tablets
Sun Pharma UK Limited are recalling the batches of tablets specified in the table as a precautionary measure due to failing dissolution test results reported during ongoing stability studies.
Zambon SpA, Emylif 50mg orodispersible film
Zambon SpA is recalling an affected batch as a precautionary measure due to out of specification results for unknown impurities during ongoing stability testing.