Over 75 000 faulty Yaz Plus packs distributed in southern Africa

More than 75 000 packets of the birth control pill Yaz Plus were affected by a packaging error that resulted in them containing only four hormone tablets instead of the required 24, compromising the product’s contraceptive efficacy.

The 75 294 packs from batch WEW96J, which have been recalled, were distributed in South Africa, Botswana, Namibia, Lesotho, Zimbabwe and Mauritius, the South African Health Products Regulatory Authority (Sahpra) told the Mail & Guardian.

The error was picked up by a pharmacist and a patient, the regulatory authority said. 

Earlier this month, pharmaceutical company Bayer issued a statement about the recall, saying it was initiated because of the discovery of a limited number of YAZ Plus packs from the compromised batch in retail pharmacies with a mix-up in the sequence of hormone-containing and hormone-free tablets.

Because the compromised packs only have four days of the active pill, if a user has sex the preceding five days then they are at risk of falling pregnant and must take emergency contraception — the morning after pill — said Dr Judith Kluge, a gynaecologist and expert on contraceptive science.

“This is an emergency contraceptive issue because all these women are at risk of being pregnant and who is liable?” Kluge said.

“The problem is we don’t have such good health systems so it depends on the individual doctor who prescribed it [contraceptive]. We don’t have the manpower to check who got a Yaz Plus prescription. All of this is essentially a contraceptive emergency.”

Sahpra said a limited number of packs were affected by this quality issue and that this was evidenced by the fact that pharmacies and patients only started picking this up with later packs. 

The batch was manufactured on 26 April 2023, packaged from 7 to 9 August 2023, and released on 9 and 24 November 2023.

“Unfortunately, as the recall is ongoing, we are unable to provide a tally of returned packs,” the regulatory authority said. The recall was initiated on 21 November.

Sahpra said the recall is ongoing as per its guidelines and an interim report will be provided by the manufacturer two weeks after the recall implementation date. Another report will be issued 30 days post the recall date.

Asked whether there had been an investigation into how the mix-up occurred, Sahpra said the investigation was ongoing.

The department of health said it could not ensure that all patients and healthcare providers were aware of the Yaz Plus batch recall because the contraceptive is not provided at public health facilities, is not on the essential medicine list and is not on tender. 

“The department of health does not have data of women affected by defect batches because Yaz Plus contraceptives are not provided at the public health facilities. However, any clients presenting to public health facilities with any complication will be evaluated and managed accordingly,” the department said.