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Sodium chloride solution products recalled due to potential contamination

Eyewash products have been recalled by Legency Remedies due to a possible microbiological contamination.

Posted on 05 April 2024

The recall of 0.9 % sodium chloride solution was announced by the Medical and Healthcare products Regulatory Agency (MHRA) due to a potential contamination of Ralstonia pickettii (a type of waterborne bacteria).

Manufacturer Legency Remedies say that the below sodium chloride products may be contaminated with a waterborne bacterium that could lead to infections.

  • Sodium Chloride Irrigation Solution 0.9% w/v supplied by Crest Medical Limited
  • Sodium Chloride Eye Wash Solution 0.9% w/v supplied by Alissa Healthcare Ltd
  • Sodium Chloride Inhalation Solution 0.9% w/v supplied by Aero Healthcare Ltd

MHRA says Ralstonia picketti has the potential to cause infections to those with compromised immune systems. It is reported that three cases have been confirmed in the UK and a small number of other cases are being investigated. So far all of the confirmed cases have received treatment and recovered.

Legency Remedies Ltd conducted seven batch tests which did not meet sterility standards. The affected batches of sodium chloride were removed and disposed of before being sold in the UK. However, as a precautionary measure, Legency Remedies have also recalled all 0.9% sodium chloride solutions for irrigation, inhalation, and eyewash that were manufactured from April to November 2023.

The recall comes shortly following a superbug outbreak that affected dozens of people in the UK and led to one fatality due to contaminated eyedrops manufactured by Indiana Ophthalmics.

Consumers are advised to check if they have any of the affected batches, as listed in the MHRA recall notice. If the products are affected, consumers should stop using them immediately and return them to the store that they were purchased in.

Leigh Day product safety partner Jill Paterson said:

“Although the risk to the general public is thought to be low, it is still crucial that consumers check their products to ensure that they are not affected.”

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