MHRA - Medicines and Healthcare products Regulatory Agency

04/05/2024 | Press release | Distributed by Public on 04/05/2024 11:00

Precautionary recall of some sodium chloride solutions for irrigation, eyewash and inhalation, manufactured between April and November 2023

News story

Precautionary recall of some sodium chloride solutions for irrigation, eyewash and inhalation, manufactured between April and November 2023

Batches of some products made by Legency Remedies Pvt Ltd have been found to contain a bacteria called Ralstonia pickettii (R. pickettii). All potentially affected batches are being recalled following an MHRA investigation.

Batches of irrigation, inhalation and eyewash solutions manufactured by Legency Remedies Pvt Ltd are being recalled as a precaution, due to potential contamination with the bacteria Ralstonia pickettii.

Whilst Ralstonia pickettii rarely causes an infection and the health risk to most people is very low, individuals with a weakened immune system are more likely to be affected. Those using the affected products should stop doing so and return them to their supplier or retailer.

These products have a wide range of uses within healthcare settings such as hospitals, but can also be used outside of healthcare organisations, for example as part of first aid kits purchased from shops.

The brand names of the affected products are:

  • Sodium Chloride Irrigation Solution 0.9 % w/v 20 ml (Blue Dot)
  • Sodium Chloride Inhalation Solution 0.9 % w/v 2.5 ml
  • Aerowash 20 ml Eyewash

Individuals and organisations can check if they have any of the affected batches listed in the company's Field Safety Notice (FSN) by looking for the batch numbers on the product packaging. Any affected products should be returned promptly to their original place of purchase. This will only affect products manufactured by Legency Remedies Pvt Ltd between April and November 2023.

If you have been using a recalled product and have been feeling unwell, for example experiencing shaking or shivering and a raised temperature, you should inform a healthcare professional.

Retailers have been advised, where possible, to contact patients who have purchased any of the affected batches and ask them to return the product.

The MHRA has published a Devices Safety Information notice to notify those within healthcare settings, including hospitals and care homes, of the recall.

Further information

R. pickettii is a type of waterborne bacteria that has the potential to contaminate healthcare products. It rarely causes infections but when it does so, is more likely to adversely affect people with a weakened immune system.

The UK Health Security Agency (UKHSA) is investigating a cluster of R. pickettii cases. There have also been similar cases reported in Australia.

Analysis of the UK and Australian R. pickettii samples from affected cases show that they are very closely related which suggests they share a common source. The Australian cases were linked to contaminated saline products utilised for irrigation and eyewash purposes in healthcare and care facilities.

The MHRA asks anyone who suspects they may have become unwell after using these products, or their healthcare professional, to report it the MHRA's Yellow Card scheme.

  • The MHRA's Device Safety Information notice is available here.
  • The manufacturer's field safety notice (FSN) issued to its customers is available here.
  • The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.  All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
  • The MHRA is an executive agency of the Department of Health and Social Care.
  • For media enquiries, please contact the [email protected], or call on 020 3080 7651.

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Published 5 April 2024