SAHPRA and Botswana Medicines Authority partner to enhance medicines regulation in the region
Pretoria, South Africa, 28 April 2024 – The South African Health Products Regulatory Authority (SAHP...
28 April, 24
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News and Updates
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SAHPRA recalls two batches of Benylin Paediatric Syrup
Pretoria, 13 April 2024 – On 10 April 2024, the South African Health Products Regulatory Authority (...
13 April, 24 -
SAHPRA signs MoU with Rwanda Food and Drug Authority
Kigali – Rwanda, 12 April 2024 – The South African Health Products Regulatory Authority (SAHPR...
12 April, 24 -
SAHPRA invests in patient safety – announcing new graduates
The South Africa Health Products Regulatory Authority (SAHPRA), in collaboration with Pharmacometric...
04 April, 24
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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
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IV Tranexamic acid – Administration error via the intrathecal route
There have been several cases around the world in which Tranexamic acid has been administered intrat...
21 December, 23 -
A Signal Of Myocarditis / Pericarditis Associated With Pfizer-biontech’s Covid-19 Vaccine, Comirnaty (Bnt162b2)
The South African Health Products Regulatory Authority (SAHPRA) would like to inform you of a signal...
19 October, 21 -
Risk of Drug-Induced Liver Injury associated with the use of Esbriet®
In collaboration with the South African Health Products Regulatory Authority (SAHPRA), Roche Product...
10 November, 20 -
MSA Diphenhydramine-containing Medicines
SAHPRA alerts all healthcare professionals about the risk of serious heart problems, seizures, coma ...
01 November, 20
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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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