Lubria-A recalled due to contamination concerns

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The South African Health Products Regulatory Authority (SAHPRA) has taken action to recall Lubria-A, a medical sterile lubricating jelly, following contamination concerns.

The decision comes in response to an investigation launched by the National Institute for Communicable Diseases after an unusually high number of patients tested positive for fungus cultures.

National Health Department spokesperson Foster Mohale emphasized the importance of healthcare professionals closely monitoring patients who may have used the recalled product.

Mohale says, “Healthcare professionals who have used this product have been urged to monitor their patients for any signs of an infection and to liaise with their local laboratories to check if any of their hospitalised patients have had a positive fungal culture after use of this product.”

The ongoing efforts aim to prevent potential health risks and promote healthy lifestyles within the community.

According to the NICD, current evidence suggests that a potential source of this fungus may have been a contaminated medical lubricating jelly used by health professionals across the health system in the country.

“This could have introduced the fungus into the bloodstream or other body sites in some patients,” the department explained.

An independent outbreak investigation conducted by the Western Cape provincial government earlier this year revealed that clusters of cases at two Cape Town hospitals may have been linked to the use of contaminated batches of lubricating jelly sachets.

The department said most of the cases at one Western Cape hospital were assessed to be pseudo-infections.

“This product has since been confirmed to be used by facilities with clusters of cases in several other provinces.”