Bayer Recalls Faulty Yaz Plus Contraceptive Packs: SAHPRA Issues Urgent Public Alert

The South African Health Products Regulatory Authority (SAHPRA) flagged the issue, affecting batch number WEW96J, distributed between 9 and 24 November 2023.

Bayer, a leading multinational pharmaceutical and biotechnology firm, has issued a nationwide recall of a specific batch of its Yaz Plus oral contraceptive pills following reports of a packaging error.

The South African Health Products Regulatory Authority (SAHPRA) flagged the issue, affecting batch number WEW96J, distributed between 9 and 24 November 2023. The problem involves the incorrect arrangement of hormone-containing and hormone-free tablets, potentially compromising the contraceptive efficacy.

Details of the Issue

According to SAHPRA, affected packs incorrectly include 24 light orange hormone-free tablets and four pink hormone-coated tablets, instead of the standard 24 pink hormone-coated tablets and four orange hormone-free tablets.

"This error could render the product ineffective as a contraceptive, potentially exposing users to an unintended risk of pregnancy," SAHPRA explained in a public statement.

Urgent Call for Consumer Action

SAHPRA CEO, Dr. Boitumelo Semete-Makokotlela, emphasized that the recall is a necessary step to protect public safety.

“We urge all users to immediately check the batch number on their Yaz Plus packs. Those in possession of batch number WEW96J should discontinue use, return the pack to their pharmacist, and seek a replacement from an unaffected batch or request a refund,” she advised.

Women are further encouraged to consult their healthcare providers for alternative contraceptive options while transitioning from the faulty batch.

Next Steps in the Recall Process

SAHPRA is working closely with Bayer to expedite the withdrawal of the affected batch from pharmacies and distribution centers. Pharmacists have been instructed to:

Remove Yaz Plus packs from batch WEW96J from their shelves immediately.

Provide replacements from unaffected batches or issue refunds to affected consumers.

Guide consumers on alternative contraceptives if needed.

Bayer has reiterated its commitment to ensuring the safety and efficacy of its products, expressing regret for the inconvenience caused. The company has established a toll-free support line for affected consumers seeking guidance or refunds.

Public Health Implications

While the recall addresses a specific quality control issue, it underscores the critical need for stringent oversight in the pharmaceutical sector. SAHPRA reassured the public that it will continue monitoring Bayer’s compliance with the recall process and conduct a thorough investigation to prevent similar incidents in the future.

How to Check and What to Do

Consumers are advised to locate the batch number, usually printed on the side or back of Yaz Plus packaging, and verify whether it matches WEW96J. If so, they should:

Immediately stop using the contraceptive.

Return the pack to the pharmacy where it was purchased.

Consult a healthcare professional for further advice or alternatives.

This proactive step by Bayer and SAHPRA highlights the importance of addressing pharmaceutical safety issues promptly to maintain public trust in essential healthcare products.