The South African Health Products Regulatory Authority (SAHPRA) has urged those who purchased Lubri-A (Sterile Lubricating Jelly) to return the product.
This as a number of patients became ill due to developing a
fungal infection, after using the 2.5 g sachets or 50 g tubes product.
‘’Considering the wide usage of the product for lubricating
purposes in medical and surgical procedures, the Regulator has taken a decision
to urgently recall this product from the market as there are multiple
contaminated batches, with the potential to cause serious and widespread
nosocomial infections. SAHPRA is alerting healthcare professionals and the
public to discontinue the use of the product, remove it from their inventory
and return it through their normal distribution channel(s) with immediate
effect,’’ said SAHPRA in a statement.
The health regulatory authority said the countrywide recall
is being done through hospitals, retail outlets, health care professionals,
authorised prescribers and individual customers or patients.
SAHPRA assured citizens that the recall is limited to the
product called LUBRI-A (2.5g sachets and 50g tubes) and does not affect other
lubricating gel products authorised for sale in South Africa.
“As a national
regulatory authority, the recalling of medical products is a crucial measure to
address safety concerns or quality issues so that we protect the health of the
public. SAHPRA is recalling this product from the market as there are multiple
suspected contaminated batches with the potential to cause serious and widespread
nosocomial infections,” said Dr Boitumelo Semete-Makokotlela, SAHPRA CEO.
Done By: Mitchum George
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