The South African Health Products Regulatory Authority (SAHPRA) says it will continue to monitor the implementation of actions by pharmaceutical company Adcock Ingram at its Clayville, Gauteng, production facility to ensure the facility meets the necessary good manufacturing practices (GMP) standards.

This follows the recall of several batches of Citro-Soda Regular products manufactured at the facility between April 2024 and December 2025 and sold in South Africa and exported to nine other African countries.

After announcing the recall on March 20, the SAHPRA on March 24 briefed the media on what led to the recall and which products were affected.

The authority stressed that the recall only affected the Citro-Soda Regular products manufactured at the Clayville facility and not the Citro-Soda Cranberry products manufactured by Adcock in Bangalore, India. Adcock in a March 20 recall notice also stated that Citro-Soda Regular products manufactured at facilities other than its Clayville plant were not affected.

Meanwhile, SAHPRA inspectorate and regulatory compliance head Lebogang Mazibuko pointed out that the authority had carried out various inspections in different parts of Adcock's Clayville facility in recent years, explaining, however, that the large facility was made up of different production lines.

It was only after a whistleblower lodged a complaint with the authority earlier this year that the focus turned specifically to the Citro-Soda production area within the facility. The SAHPRA conducted an inspection of this particular area in February.

Mazibuko said the authority had identified critical GMP deficiencies at the production area, including metallic and black residue on equipment, posing a risk of contamination of the product; the absence of a suitable air handling system; ineffective and inconsistent cleaning procedures; and damaged, rusted and poorly maintained equipment.

The authority determined that these deficiencies might lead to harm to consumers, prompting it to issue enforcement actions to Adcock. It noted, however, that, thus far, no adverse reaction has been reported to the authority.

The SAHPRA also emphasised that it did not have concerns about the safety of other products manufactured at the Clayville facility.

The products affected by the recall include batches of Citro-Soda Regular 60 g, Citro-Soda Regular 120 g and Citro-Soda Regular 4 g x 30 Sachets, expiring before November 2027. The products manufactured at the Clayville facility are clearly marked with batch numbers starting with a C, for example C133477.

Citro-Soda produced at other facilities and that are not affected by the recall have batch numbers that start with PC, PB or AG.

Adcock has advised retail pharmacies, wholesalers and distribution centres to refrain from selling any affected batches and to return these products to their supplying warehouse or distribution centre. Consumers, meanwhile, are requested to return any impacted stock to the point of purchase for credit or stock replacement.

*Engineering News has reached out to Adcock Ingram for comment.