The South African Health Products Regulatory Authority (SAHPRA) has recalled specific batches of Citro-Soda Regular, following the discovery of potential contamination risks at the Adcock Ingram manufacturing facility in Clayville, Johannesburg.
Image credit: Dis-Chem
The recall affects Citro-Soda Regular 60g, 120g, and 4g sachets, with batch numbers starting with the letter “C,” all produced at the Clayville site.
Products manufactured at other facilities, including those produced in India, are not affected.
Problems at manufacturing facility
SAHPRA CEO, Dr Boitumelo Semete-Makokotlela, confirmed the recall during a media briefing in Pretoria, saying the move demonstrates the regulator’s commitment to public safety.
The CEO assured the public that the decision to recall the product followed a thorough inspection of the facility and a detailed assessment of its manufacturing practices.
“As a regulator, our mandate is to ensure that every health product you consume is of good quality, safe and effective...when we become aware of any details that indicate that there is any compromise of the quality, safety or efficacy of health products, we will act, and we will do so decisively,” she said.
The recall follows an inspection prompted by a whistleblower report that uncovered serious noncompliance with Good Manufacturing Practice (GMP) standards at the Clayville facility.
SAHPRA has urged consumers to report any quality defects they come across.
“We would like to urge the public that as part of the country, as citizens of the country, and as those who consume these products, please do alert us of any quality defects that you encounter, with any health product available in the country,” Semete-Makokotlela said.
SAHPRA inspectorate and regulatory compliance head, Lebohang Mazibuko, said critical deficiencies were identified, including contamination risks from metallic and black residues on equipment.
“We found (the) presence of metal fragments from the manufacturer equipment and some unknown black particles from those manufacturing equipment.
"Those metal fragments were from the manufacturing vessels that are used to manufacture this product. Hence, we say you cannot consume a metal and be well after that,” Mazibuko said.
Other issues included inadequate cleaning procedures, damaged and rusted equipment, and the absence of proper air handling systems to control contamination.
SAHPRA emphasised that the recall is limited to affected batches of Citro-Soda Regular produced at the Clayville facility and does not extend to other products manufactured by Adcock Ingram.
Recall at all distribution channels
Regulatory compliance manager Mokgadi Daphney Fafudi said the recall is being implemented across all distribution channels, including pharmacies, hospitals, clinics, and retail outlets.
“The public needs to note that this is not a withdrawal of a product, but it's a recall of batches that do not comply, and these can be returned to the nearest facilities, whether it's a health facility or a retail facility.
"Otherwise, they can contact Adcock Ingram; the contact details are available on our website,” she said.
The regulator further urged consumers to take note of the batch numbers when purchasing the product.
“We have only recalled the batch numbers that start with C of the regular Citro-Soda, all regular Citro-Soda with batch that starts with C, which are also listed on the recall notice are the ones that are affected,” Fafudi emphasised.
The SAHPRA will closely monitor both the recall process and compliance at the facility until all affected batches have been removed.
“We will monitor this recall up until all the batches have been recalled and they have been destroyed.
"And we will also monitor compliance of the site up until they have satisfactorily addressed the corrective actions and the preventative actions that are required that were also prescribed,” she said.
