The South African Health Products Regulatory Authority (SAHPRA) has issued an urgent recall of YAZ PLUS contraceptive pills following a significant packaging error that could jeopardise the contraceptive efficacy for women.
The recall affects a specific batch of the medication, identified as batch number WEW96J, which is manufactured by Bayer (Pty) Ltd.
SAHPRA categorised the recall as Class II, Type A, aimed at addressing medications that may lead to temporary or medically reversible adverse health problems.
The Type A designation means that the recall is intended to reach all suppliers of the affected medicines, ensuring that public health remains a priority.
SAHPRA spokesperson Madimetja Mashishi said: "SAHPRA is collaborating with the manufacturer to ensure a speedy recall“.
He urged those in possession of the YAZ PLUS batch WEW96J to stop usage immediately and return it to their pharmacists for a replacement from an unaffected batch or to request a refund.
The recall came to light after reports of a limited number of YAZ PLUS packs containing an incorrect sequence of hormone-containing and hormone-free tablets were discovered in retail pharmacies.
Instead of the correct arrangement of 24 pink hormone tablets followed by 4 light orange hormone-free tablets, the defective packs included 24 hormone-free tablets and only 4 hormone tablets. This alteration compromises the contraceptive effectiveness, as some packs may contain simply insufficient hormone tablets.
Dr Boitumelo Semete-Makokotlela, CEO of SAHPRA, reiterated the necessity of this precautionary measure.
"We urge members of the public who are in possession of YAZ PLUS Batch No. WEW96J to discontinue use and return the packaging to their pharmacists," she affirmed, indicating that collaboration with Bayer was underway for an expedited recall process.
Bayer has also called on all stakeholders, including healthcare professionals, retail pharmacies, hospitals, and individual patients with the affected batch, to return the product to the dispensing healthcare facility for credit.
They have highlighted the limited scope of this incident, clarifying that corrective measures have been instated and that this issue is confined solely to this specific batch.
"If you are in possession of YAZ PLUS tablets from the affected batch, you are urged to stop use immediately and contact your healthcare professional. While only a limited number of packs from the respective batch are affected, it is crucial that no tablets from these packs should be used until you have consulted your healthcare practitioner," Bayer advised.
Bayer urged those who may have already consumed tablets from the affected batch or who have concerns regarding their contraceptive coverage to immediately consult their healthcare provider.
"This incident is limited to only this one batch and no other batches are impacted," the company said in a statement. reassured.
Thembi Zulu, the Deputy Director of Women's Health at the National Department Health said that YAZ PLUS was not being provided in public facilities.
"Even though we don’t supply YAZ PLUS, I’ve been told that only a few of the batch was affected and recalled. My advice for the private sector is to give the women alternative contraceptives while the matter is being sorted out,” said Zulu.