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News and Updates


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Databases and Registers

OTC Medicine Information

The Medicines’ Online Directory provides healthcare professionals and the consumer with a guide to all SAHPRA registered over-the counter (OTC) medicines that are available in South Africa without a doctor’s prescription.

Safety alerts


The hotline has been established with the aim of enhancing an honest work ethic and simultaneously providing the public with a mechanism to bring any unethical business practices to the attention of management.

Product Recalls

Benylin Paediatric Syrup (Each 5 Ml Contains 7 Mg Diphenhydramine HCl)

On 10 April 2024, the South African Health Products Regulatory Authority (SAHPRA) received a report from National Agency for Food and Drug Administration and Control (NAFDAC) regarding detection of high levels of Diethylene glycol in a batch of Benylin Paediatric medicine.

Lubri-A Sterile Lubricating Sachets (Glycerine (B.P. Or U.S.P) 9.9% M/M)

The recall was initiated because of numerous complaints received by SAHPRA due to a countrywide outbreak across the country regarding patients who developed a rare fungal pathogen, Wickerhamomyces anomalus (previously Candida pelliculosa), following the use of Lubri-A use. Following a collaborative outbreak investigation, the source was found to have contaminated several batches of the product, Lubri-A-Sterile Lubricating 2.5 g Jelly sachets.

Amuco 600 Effervescent Tablet (Acetylcysteine 600mg)

The recall was initiated because some of the containers possess defective primary packaging, resulting in the loosening of the seal on certain packages. The company confirmed that this faulty seal, combined with the hygroscopic nature of the product, causes the product to become moist.

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