Deficiencies at Clayville facility prompt Class II recall of Citro-Soda products

The South African Health Products Regulatory Authority (SAHPRA) has announced a recall of certain batches of Citro-Soda following a potential contamination risk at the Adcock Ingram Clayville manufacturing facility in Johannesburg.

The regulator assured that the recall only affects batches produced at the Clayville facility, adding that it has no concerns about any other products manufactured by pharmaceutical company Adcock Ingram.

Citro-Soda, one of Adcock Ingram’s hallmark brands, is an effervescent, granulated treatment designed to relieve symptoms of acid-related digestive issues and urinary tract conditions by acting as a gastric antacid and urinary alkaliniser.

Citro-Soda products are widely sold in the country.

SAHPRA issued a Class II recall last week for the product made at Adcock Ingram’s Clayville plant in Johannesburg, following a whistleblower notification. This led to an inspection, which found critical deficiencies and resulted in enforcement action against the company.

A Class II recall is issued for risks deemed to be temporary or reversible.

Lebogang Mazibuko, SAHPRA’s senior manager for inspectorate and regulatory compliance, said some of the deficiencies inspectors found include damaged and rusty machinery, fragments of metal in manufacturing vessels, a damaged and poorly maintained conveyor belt, residue on machinery, and inadequate cleaning procedures.

“Therefore, these critical deficiencies identified during the inspection at Adcock Ingram Clayville have the potential to produce a product that can significantly harm patients, or result in a product that might be harmful to patients or the public,” said Mazibuko.

The regulator emphasised that the recall only applies to Citro-Soda Regular batches numbered “C” produced at the Clayville plant, which expire on or before November 2027, excluding any flavoured batches.

SAHPRA said its actions were prompted by an investigation by Carte Blanche, which aired last month and highlighted alleged problems at the Clayville plant.

The affected batches, which were destined for South Africa and nine other African countries, amount to tens of thousands of units, said Mazibuko.

The regulator added that other manufacturing plants in various countries, including India, are not affected. It also noted that Adcock Ingram pursues a dual manufacturing strategy, in which key products are produced at different sites to ensure continuity of supply.