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Accord-UK Ltd have informed us that important safety warnings for the excipient Propylene glycol are missing from the patient information leaflet (PIL).
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Orion Corporation T/A Orion Pharma (UK) Ltd are recalling specific batches as a precautionary measure due to an issue related to moulding defects in the bulk chambers where the inhalation powder is stored.
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SyriMed are recalling the below batch as a precautionary measure due to an issue related to the container closure (child-lock cap).
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Eaststone Limited has informed us of an issue related to underfilled or empty bottles for MidaBuc - Midazolam (as HCL) 10mg/mL Oromucosal Solution. The below batch is being recalled.
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Gilead Sciences Ltd has informed us of a quality defect issue, in relation to specific lots of 5碌m sterile filters, which are co-packed in cartons of the AmBisome product. The medical device is called Minisart Filter 16534-鈥�
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Gr眉nenthal Ltd has informed us of a potential microbial contamination during routine stability testing for the batches listed in this recall.
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CSL Behring UK Ltd is recalling specific batches of Respreeza 1,000 mg powder and solvent for solution for infusion (EU/1/15/1006/001) due to a manufacturing deviation that occurred during the filling process.
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Takeda UK Limited is recalling a batch of Instanyl 100mcg nasal spray solution (EU/1/09/531/015) due to the observation of cracked vials during inspection of the bulk vials and release testing of the finished products.
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Medac Pharma LLP is recalling specific batches of products due to some inspected vials showing hairline damage to the shoulder of the vials. This is a second alert for further batches identified.
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Fresenius Kabi Ltd is recalling the above batch of Sodium chloride 0.9% Solution for injection (PL 08828/0178) which has a polish labelled ampoule within some of the cartons. As this does not impact the full batch, as a prec鈥�
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Merck Sharp & Dohme Limited is recalling specific batches of Zerbaxa 1g/0.5g Powder for Concentrate for Solution for Infusion as a precautionary measure due to the presence of Ralstonia pickettii in recent batches manufa鈥�
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Generics [UK] Limited t/a Mylan have informed us that the Patient Information Leaflet (PIL) within the packs for the products listed above is missing relevant important safety information.
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Lupin Healthcare (UK) Limited has informed us that the affected batches of Simvastatin tablets have been packaged with a version of patient information leaflet that does not include the most up to date safety information.
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Sanofi is recalling specific batches of Largactil 50mg/2ml Solution for Injection as a precautionary measure due to out of specification results obtained for the impurity chlorpromazine sulphoxide
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Kent Pharmaceuticals Ltd has informed us that several batches of finished product were contaminated with theophylline due to a cross-contamination issue identified with an excipient that was used in the manufacture of the fi鈥�
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Kyowa Kirin Limited is recalling specific batches as a precautionary measure, due to the reports of double tablets in a single blister pocket.
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Mylan UK Healthcare Ltd is recalling remaining stock of certain batches as a precautionary measure after a product sterility non-compliance event which occurred during a recent inspection at the contract manufacturing site.
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medac Pharma LLP is recalling a specific batch of products due to some inspected vials showing hairline damage to the shoulder of the vials.
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Intrapharm Laboratories Ltd has informed us that there is a difference in dosage instructions between the carton and label. The Patient Information Leaflet (PIL) and bottle label contain the correct instructions.
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Theramex Ireland Ltd T/A Theramex HQ UK Ltd has informed us of an issue related to error in the decommissioning of a further batch. Upon decommissioning at the pharmacy and when scanning the serialised 2D code, the status of鈥�
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Guerbet Laboratories Limited is recalling certain batches of products as a precautionary measure due to reports received from healthcare professionals on the difficulties in attaching the Luer lock adapter to the Luer tip of鈥�
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Accord Healthcare Ltd has informed us that when decommissioning at the pharmacy and scanning the serialised 2D code, the status of certain packs may report as 鈥楨XPORT.鈥�
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Sanofi is recalling batches of product as a precautionary measure due to out of specification results for disintegration test during routine stability testing.
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The Boots Company PLC is recalling a specific batch of Hydrocortisone 1% w/w Ointment as a precautionary measure due to retained samples showing presence of Pseudomonas aeruginosa.
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Medicines from the listed parallel distributors are being recalled due to concerns that the supply chain may have been compromised and the origins of the products are unknown
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Ratiopharm UK Limited and Generics [UK] Limited t/a Mylan have confirmed that the Patient Information Leaflet (PIL) within all packs and the Summary of Product Characteristics (SmPC) for Ratiopharm is missing important safet鈥�
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Accord Healthcare Limited is recalling a specific batch of Amlodipine 10mg Tablets as a precautionary measure due to out of specification results obtained during stability testing.
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GL Pharma is recalling a specific batch of Oxylan 40mg prolonged-release tablets due to out of specification results for dissolution during routine stability testing.
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Based on MHRA鈥檚 review of available data, the Commission on Human Medicines鈥� Paediatric Medicine Expert Advisory Group (PMEAG) has advised that Wockhardt UK鈥檚 Amoxicillin Sodium Powder for Solution for Injection can be used 鈥�
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Sanofi is recalling batch number A9306 of the above product as a precautionary measure due to an out of specification result detected for Rasburicase enzyme activity according to a specific method and specifications for US m鈥�
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Fresenius Kabi Ltd & Calea UK Ltd has informed us of an error on the bag labels for SmofKabiven extra nitrogen electrolyte free, emulsion for infusion PL 08828/0269.
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Huddersfield Pharmacy Specials (HPS) is recalling the above batches of phosphates solution for infusion due to observation of precipitation in batch 500609X. The decision to recall all other batches has been made as a precau鈥�
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Pharmaram Ltd has informed us that a specific batch of Clexane 4,000IU (40mg)/0.4ml syringes has an error on the labelling affixed to the plastic blister packaging encasing the syringe.
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Accord-UK Ltd has informed us of an issue related to decommissioning of a specific batch
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Kyowa Kirin Limited is recalling a specific batch as a precautionary measure, due to the reports of double tablets in a single blister pocket. This was identified during reference sample inspection and there is a potential l鈥�
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Accord Healthcare Limited is recalling the above batch as a precautionary measure, due to the observation of precipitation in the solution in the same batch marketed in another country (Malta). No complaints or adverse react鈥�
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Pfizer Limited has informed us that the packs for the affected batches below have not been packaged with the current version of the Patient Information Leaflet (PIL) containing updated storage instructions of the infusion so鈥�
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Ennogen Pharma Limited has informed us that the Patient Information Leaflets (PILs) within the packs for the affected batches below contain an error in Section 3 (How To Take Trimogal Tablets) with regard to the dosage instr鈥�
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Aspar Pharmaceuticals Limited has informed us that the Patient Information Leaflets (PILs) within the ibuprofen packs below are missing some information identified from post-marketing experience that should be documented in 鈥�
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Ferring Pharmaceuticals Limited is recalling all unexpired stock of the products below from pharmacies and wholesalers as a precautionary measure due to a lower volume of solution being observed in the bottles, and out of sp鈥�
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Dr Reddy鈥檚 Laboratories (UK) Limited is recalling all unexpired stock of a specific batch of Nitrofurantoin 50mg Tablets from pharmacies and wholesalers as a precautionary measure due to out of specification results for diss鈥�
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BCM Specials Limited is recalling a specific batch of Mepacrine Hydroxychloride 100 mg tablets due to a number of foreign body particulates found in the containers of the API used to make it.
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Drugsrus Ltd (distributor) / Tenolol Ltd (MA Holder) has informed us of a typographical error in active ingredient stated on the label on the vial.
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Torbay Pharmaceuticals is recalling specific batches of Epistatus (Midazolam) 10mg/mL Oromucosal Solution (Multi Dose Bottles) due to a potentially faulty and incorrectly engaged child-resistant container closure.
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This covers issues with both laboratory based tests for COVID-19 antibodies (unvalidated sample type) and capillary blood sample collection kits (unvalidated for home use)
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Torbay Pharmaceuticals has informed us that the carton label on Sodium Benzoate (Amzoate) 2g in 10 mL Sterile Solution for injection incorrectly states the concentration of disodium edetate (excipient) as 0.1% w/v (10mg in 1鈥�
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As a precautionary measure, Pfizer Limited is recalling the above batches from wholesalers due to out of specification results from the ongoing stability studies. An evaluation of the foil laminate pouch identified oxygen le鈥�
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Pharmaswiss 膶eska republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerade 500 microgram auto-injectors (also referred to as pens) from patients due to an error in one com鈥�
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GSK has informed us that due to a machinery defect with the printing line, a small number of packs may not have the batch number and expiry date printed on the outer cartons. The correct information is printed on the blister鈥�
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TEVA UK Limited has informed us that the Product Code/GTIN (PC) number found on the below batches is incorrect.