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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
Bristol-Myers Squibb Pharmaceuticals Limited has informed the MHRA that a potential product quality issue has been detected, relating to incomplete crimping of the metal crimp cap of OPDIVO 10mg/mL concentrate for solution for infusion (nivolumab) (1VLX10ML).
Product Recall for 3M™ Heavy Duty Breathing Tubes presenting a health risk.
Besins Healthcare (UK) Ltd has informed the MHRA that a defective pump system was detected in two batches of Oestrogel Pump-Pack 750 micrograms/actuation Gel.
Product Recall for LAX, Gentek, Cleverworks and Brookstone Wireless Chargers presenting a risk of burns.
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).
Neon Healthcare Ltd is recalling the specific batch mentioned in this notification as a precautionary measure.
List of Field Safety Notices from 20 to 24 May 2024.
The MHRA has been made aware that falsified medical oxygen has been provided to several dental practices across the UK.
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.
Product Recall for Merkury Innovations, Lifestyle Advanced, Simplytech and Tech Theory Wireless Chargers presenting a risk of burns.
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.
Product Recall for 3M Face Shield presenting a risk of kinetic energy/high-speed flying particles.
Advice for manufacturers of Class I medical devices for placing products on the UK market
Tillomed Laboratories Limited is recalling one batch of Labetalol 200mg Tablets due to an error on the foil blister packaging.
Product Recall for 3M™ Peltor™ X-series P5 Over the Ear Earmuffs (helmet attached) presenting a health risk.
Information about the EU Regulations and their implementation in Northern Ireland
Alerts industry to specific issues. Normally time sensitive and action may be required.
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
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