Adcock Ingram says it has started recalling batches of Citro-Soda after an inspection by the South African Health Products Regulatory Authority (Sahpra).
The pharmaceutical company said it is acting immediately to implement the required actions. “This is to ensure ongoing compliance with regulatory and quality standards … we are co-operating fully with Sahpra,” it said, adding that the batches being recalled were ones made only at the Clayville site.
The health regulatory body said it had identified the Clayville facility in Johannesburg as having a contamination risk. Sahpra CEO Dr Boitumelo Semete-Makokotlela said an evaluation of the facilities’ manufacturing practices led to the regulator deciding to recall the batch.
“Adcock Ingram can confirm that Sahpra has concluded an inspection at the company’s Clayville production facility … This recall does not affect Citro-Soda Regular manufactured at other Adcock Ingram manufacturing sites. This recall also does not affect Citro-Soda Cranberry," the company said.
“Adcock Ingram’s priority remains focused on patient safety and product quality.”
Sahpra announced the recall on Tuesday after it identified the batches as a contamination risk. Lebohang Mazibuko, Sahpra manager of inspectorate and regulatory compliance, said inspectors identified several critical failures during a site inspection conducted on September 24.
“Metallic and black residues were found on clean manufacturing equipment, posing a risk of contamination. There was also no suitable air-handling system to control dust and prevent contamination,” she said.
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