The UK MHRA has announced in the alert letter that about 0.23% syringe pens (2.3 pens in every 1,000) manufactured by Bausch & Lomb fails to deliver adrenaline’s dose due to needle blockage.
The warning letter is only meant for the Emerade solution for injection in pre-filled syringes of 150µg, 300µg and 500µg.
The regulatory agency also informed that due to the shortage of alternative drugs in the market, they are not recalling any product batches. Two alternative drugs that are available in the market, does not show the action in same way and require specific training.
The agency informed that the company has investigated the cause and implemented the corrective actions.
The agency observed the issue on Emerade in June 2018, with 0.15% potential failure rate at that time. However, the potential failure rate increased in recent detections and lead to the warning letter.
MHRA suggested that the anaphylactic patients must carry two in-date pens with the device as the failure rate in them is very less.
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