Field Safety Notices: 23 to 27 June 2025
List of Field Safety Notices from 23 to 27 June 2025.
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Early Alert: Infusion Pump Software Issue from Baxter
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program -
Healwell Homeo Private Limited – 706206 – 06/12/2025
CGMP/Finished Pharmaceuticals/Adulterated -
Early Alert: Blood Pump Controller Issue from Abiomed
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program -
FDA’s Labeling Resources for Human Prescription Drugs
FDA’s Labeling Resources for Human Prescription Drugs -
“Peter Michael, M.D. – 711299 – 06/18/2025
Clinical Investigator -
FDA requires expanded labeling about weight loss risk in patients younger than 6 years taking extended-release stimulants for ADHD
The U.S. Food and Drug Administration (FDA) is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD) – including certain formulations of amphetamine and methylphenidate – to warn about the risk of weight loss and other adverse rea -
Decision: Human medicines: register of electronic export certificates
Department of Health and Social Care and MHRA register of electronic export certificates (human).
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Drug Shortages | Additional News and Information
Drug Shortages: Additional News and Information -
Aurum pre-filled syringes phased introduction of new 10ml CONNECT syringe barrel: Importance of selecting compatible needle-free connectors to minimise the risk of syringe blockage (DSI/2025/02)
Due to a phased introduction of the new 10ml CONNECT barrel design for the Aurum pre-filled syringes, the range of compatible needle free connectors (NFCs) differs between the established syringe barrel and the new syringe barrel. It is vital that healthcare professionals use compatible NFCs with Aurum pre-filled syringes to prevent delays to delivery of emergency medication.
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Class 4 Medicines Defect Notification: Erythromycin Stearate BP 250mg Tablets, Amdipharm UK Ltd, EL(25)A/32
Amdipharm UK Ltd has informed MHRA that the Patient information leaflet (PIL) in the cartons for the batch listed in this notification includes a superseded PIL.
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FDA 483, dated June 11, 2008, (9 pages)
FDA 483, dated June 11, 2008, (9 pages)