Recalls are classified into both the Class according to the level of health hazard involved (risk to the patient) and Type which denotes the depth or extent to which the product should be recalled from the distribution chain [e.g. Class II, Type C recall].
NOTE: Decision on the Class and Type of a recall to be initiated is a subject approved by SAHPRA in consultation with the HCR and shall be based on the evidence and/or expert opinion of SAHPRA and HCR.
The list of recalls provides information gathered from notification from Holder of Certificate of Registration (HCR)/ Pharma Industry. SAHPRA works with HCR to publish media/ press releases and other public notices about recalls that may potentially present a significant or serious risk to the consumer or user of the medicine/ medicinal product. Not all recalls have media / press release or are posted on this page.
Medicine/ Medicinal product withdrawal from the market
SAHPRA can recommend the withdrawal of a medicine following a review that considered all available information not relating to safety, quality and efficacy.
In the case of the decision by the HCR to voluntarily withdraw their medicine from the market, it is their responsibility to notify SAHPRA.