Regulatory Updates
FDA, EMA, TGA and global regulatory developments
Regulatory Updates
Aug 23, 2026•1 min read
MHRA Issues Updated Guidance on Defects in Belzer Organ Preservation Solutions
The MHRA has issued an updated Drug Safety Information (DSI) replacing DSI/2023/005, addressing defects in Belzer solutions used for organ preservation.
Regulatory Updates
Aug 23, 2026•1 min read
MHRA alerts on medical devices lacking valid UKCA/CE markings
MHRA warns that several medical devices on the UK market do not meet UK MDR 2002 or EU requirements and must be removed from use and quarantined.
Regulatory Updates
Aug 23, 2026•1 min read
MHRA Issues Field Safety Notices for 3‑7 August 2026
The MHRA released a list of Field Safety Notices covering the period 3 to 7 August 2026.
Regulatory Updates
Aug 23, 2026•1 min read
ResMed Field Safety Notice: Astral 100/150 Ventilators May Interrupt Therapy
ResMed issued a Field Safety Notice for Astral 100 and 150 ventilators and related PCB spare parts made before Oct 2024, citing a fault that could unexpectedly interrupt ventilation.
Regulatory Updates
Aug 23, 2026•1 min read
MHRA publishes Field Safety Notices list for 13‑17 July 2026
The UK Medicines and Healthcare products Regulatory Agency released a list of Field Safety Notices issued between 13 and 17 July 2026.
Regulatory Updates
Aug 23, 2026•1 min read
MHRA Advises Against Use of Rectal Catheters for Infants
The UK MHRA warns that rectal catheters marketed as gas and colic relievers must not be used in infants for colic, gas discomfort or constipation. Users should stop and dispose of devices.
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Regulatory Updates
Aug 23, 2026•1 min read
Zentiva UK Pharma recalls Fingolimod 0.5 mg capsules over metal contamination risk
Zentiva UK Pharma Limited is recalling a batch of 0.5 mg Fingolimod capsules due to possible metal particle contamination.
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Regulatory Updates
Aug 23, 2026•1 min read
Label Mixup Recall: Potential Mislabeling of Famotidine 20 mg Tablets
The FDA reports a labeling mixup where Famotidine 20 mg tablets may be mislabeled as Carvedilol Phosphate ER capsules, along with other products.
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Regulatory Updates
Aug 23, 2026•1 min read
FDA Recalls Product Over Sterility Concerns Due to GMP Violations
The FDA has initiated a recall after an inspection revealed GMP violations that could compromise product sterility.
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Regulatory Updates
Aug 23, 2026•1 min read
FDA Recalls Product Due to Lack of Assurance of Sterility
The FDA has issued a recall for a product because sterility could not be assured.
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Regulatory Updates
Aug 23, 2026•1 min read
Orbit Pharma Recalls Cyclizine Lactate Injection Batch Over GMP Deficiencies
Orbit Pharma Limited is recalling a batch of Cyclizine Lactate 50 mg/ml injection solution due to GMP deficiencies at the manufacturing site.
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Regulatory Updates
Aug 23, 2026•1 min read
MHRA Issues Field Safety Notices for 8‑12 June 2026
The UK Medicines and Healthcare products Regulatory Agency released a series of Field Safety Notices covering multiple products between 8 and 12 June 2026.