The South African Health Products Regulatory Authority has confirmed the recall of certain Citro Soda batches manufactured at Adcock Ingram’s Clayville facility, citing serious manufacturing concerns.
Officials briefed the media in Pretoria on Tuesday, outlining the reasons behind the decision and the processes followed.
SAHPRA says the recall follows an inspection triggered by a whistleblower complaint, which uncovered critical non-compliance with good manufacturing practices. The regulator maintains that the action is part of its mandate to ensure the safety, quality and efficacy of health products in the country.
Chief Executive Officer, Dr Boitumelo Semete-Makokotlela, said the recall demonstrates the authority’s commitment to acting decisively when concerns are raised.
“There is a recall of the Citro Soda product manufactured at the Clayville site. When we are made aware of any compromise in quality, safety or efficacy, we act decisively. The public must have confidence that the regulator is fulfilling its mandate,” she said.
Head of Inspectorate and Regulatory Compliance, Lebohang Mazibuko, detailed the findings, saying contamination risks were identified during the inspection.
“We discovered metallic and black residues on manufacturing equipment, inadequate air handling systems and ineffective cleaning procedures. These deficiencies create a risk of contamination and could result in products that may be harmful to patients,” Mazibuko said.
She added that the recall is limited to Citro Soda products manufactured at the Clayville facility and does not affect products made at other sites, including those produced in India.
Regulatory Compliance Manager, Mokgadi Daphney Fafudi, explained the enforcement process and classification of the recall.
“This is a Class 2, Type A recall, which means the product may cause temporary or medically reversible health effects. The recall applies across all distribution points, including pharmacies, clinics and retail outlets, and affected batches must be returned,” Fafudi said.
SAHPRA says it will continue monitoring the recall process until all affected batches are removed from circulation and has urged the public to report any concerns about product safety.
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