Class 4 Medicines Defect Information: Max Remedies Ltd, Max Healthcare Paracetamol 500 mg Capsules
Max Remedies has identified an infrequent printing error relating to the Braille text printed on the cartons of various batches of this product.
Medicine recalls page 8
Medicine recalls, drug alerts and medical device warnings from the MHRA. 609 listed.
Chiesi Ltd., Trimbow 87/5/9 mcg pressurised inhalation solution
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…
Sun Pharma UK Ltd, Gemcitabine 10mg/ml Solution for Infusion PL 31750/0062 (Single dose Infusion bag, 2000mg/200ml), CLMR(23)A/06
Sun Pharma UK Ltd has informed the MHRA of a labelling issue with one batch of Gemcitabine 2000mg/200ml infusion.
Class 4 Medicines Defect Information: Colgate-Palmolive (U.K.) Limited, Duraphat 5000ppm Fluoride Toothpaste (51g)
Colgate-Palmolive (U.K.) Limited has informed the MHRA that the Patient Information Leaflet (PIL), carton and tube of the batches of Duraphat 5000ppm Fluoride Toothpaste (51g) listed above are missing information relating to the presence…
Theramex HQ UK Ltd, Evorel Sequi
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…
Class 4 Medicines Defect Information: Kyowa Kirin Limited, Tostran (Testosterone, 2% gel)
Kyowa Kirin Limited has notified MHRA that the priming instructions in the current PIL for Tostran 2% gel require updating.
Veriton Pharma Limited, Epistatus 2.5 mg oromucosal solution, pre-filled syringe (PFS)
Veriton Pharma Limited is recalling a specific batch of Epistatus (midazolam) 2.5mg Oromucosal Solution (pre-filled oral syringes) due to confirmed out of specification results related to the product appearance.
Class 4 Medicines Defect Information: Galderma (U.K.) Limited, Loceryl 5% w/v Medicated Nail Lacquer (5.0 ml)
Galderma (U.K.) Limited has informed the MHRA that a pallet of Loceryl 5% w/v Medicated Nail Lacquer from a batch licensed only for distribution in Ireland has been inadvertently placed into the UK supply…
Class 4 Medicines Notification, Accord Healthcare Limited, UK, Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion
Accord Healthcare Ltd, UK has informed the MHRA about an error with the Patient Information Leaflets (PILs) that have been packaged in the batches of these products mentioned in this notification.
Class 4 Medicines Notification, Accord Healthcare Limited, UK, Olmesartan Medoxomil 10mg film coated tablets
Accord Healthcare Ltd, UK has informed the MHRA about an error with the Patient Information Leaflets (PILs) that have been packaged in the batches of these products mentioned in this notification.
medac GmbH (t/a medac Pharma LLP), Sodiofolin 50 mg/ml solution for injection/infusion, (100mg/2ml vial)
medac GmbH (t/a medac Pharma LLP) is recalling further batches due to particles detected during long-term stability tests.
B. Braun Medical Ltd, Various Products
B. Braun Medical Limited is recalling various product batches as a precautionary measure after traces of midazolam were detected in the batches listed in this notification.
medac GmbH (t/a medac Pharma LLP), Sodiofolin 50 mg/ml solution for injection/infusion (400mg/8ml vial)
medac GmbH (t/a medac Pharma LLP) is recalling the products and respective batches in this notification due to particles detected during long-term stability tests.
Quantum Pharmaceutical, Diltiazem HCl 2% Cream [unlicensed medicine], CLMR (23)A/05
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.
Aventis Pharma Limited (t/a Sanofi), Sabril 500 mg film-coated tablets & Sabril 500 mg granules for oral solution
Sanofi UK is recalling the listed batches of Sabril tablets and Sabril granules as a precautionary measure due to the detection of traces of tiapride in the batches of the source material of manufacturer…
Class 4 Medicines Notification, Cipla (UK) Limited and Pharmathen S.A., Various Products, EL(23)A24
Cipla (EU) Limited, UK and Pharmathen S.A. have informed the MHRA that the outer carton (box) of the product batches mentioned in this notification are missing the medicines legal classification for a Prescription Only…
Tillomed Laboratories Limited, Labetalol 200mg Tablets
Tillomed Laboratories Limited is recalling one batch of Labetalol 200mg Tablets due to an error on the foil blister packaging.
medac GmbH (t/a medac Pharma LLP), Dacarbazine 100mg, 200mg & 500mg powder for solution for injection vials
medac GmbH (t/a medac Pharma LLP) is recalling the products and respective batches in this notification due to pink discolouration of the dacarbazine solution immediately after reconstitution (after correct preparation and storage).
Strandhaven Limited T/A Somex Pharma, Sildenafil 100mg Film-coated Tablets
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.
Tricodent Limited (supplier), Medical Oxygen B.P (MEDIGAS OXYGEN B.P)
The MHRA has been made aware that falsified medical oxygen has been provided to several dental practices across the UK.
Class 4 Medicines Defect Information: Drugsrus Limited / Dawa Limited, Metronidazole 200 mg/5 ml Oral Suspension
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.
Class 4 Medicines Defect Information: Orifarm UK Ltd, Buccolam 10mg Oromucosal solution
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…
Class 4 Medicines Defect Information: Novartis Pharmaceuticals, Simulect 10mg & 20mg powder and solvent for Solution for injection or infusion
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 in…
Hikma Farmacêutica Portugal S.A., Gemcitabine 1g/26.3ml & 2g/52.6ml Solution For Infusion Vial
Hikma Farmacêutica Portugal S.A has informed the MHRA of a potential issue impacting the batches listed in this notification.