By Ncaba Ntshakala
The Ministry of Health has issued an urgent recall of a specific batch of YAZ Plus contraceptives following reports of a significant quality defect that could compromise their efficacy.
This announcement is part of a broader effort to safeguard public health in Eswatini, as the Ministry simultaneously addresses the recall of additional medications due to quality issues.
The affected batch of YAZ Plus contraceptives, identified as Batch No. WEW96J, was distributed on November 9 and 24, 2023.
The South African Health Products Regulatory Authority (SAHPRA) alerted the Ministry to the problem, which involved a manufacturing error by Bayer, the German pharmaceutical company responsible for producing the contraceptives.
Bayer confirmed that the error stemmed from a mix-up in the arrangement of hormone-containing and hormone-free tablets within certain packs.
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Instead of the standard 24 pink hormone tablets and four light orange hormone-free tablets, some packs contained 24 light orange hormone-free tablets and only four pink hormone tablets.
This misconfiguration renders the contraceptives ineffective in preventing pregnancy, posing a significant risk to users.
Minister of Health Mduduzi Matsebula assured the public that the recalled batch is not available in government or public health facilities.
However, he emphasized that efforts are underway to determine its distribution in the private sector.
The Ministry has engaged private pharmacies and healthcare providers to ensure the discontinuation of the affected product and to facilitate a comprehensive recall.
Members of the public have been urged to inspect any YAZ Plus contraceptives in their possession. Those identified as part of the recalled batch should immediately stop using the product and return it to the point of purchase.
Pharmacies and healthcare providers will offer either a refund or a replacement with the correct batch. The Ministry also strongly advised individuals who have already used the affected contraceptives to consult healthcare professionals to address any potential risks.
Minister Matsebula reaffirmed the Ministry’s commitment to managing the recall efficiently and keeping the public informed of further developments.
This announcement comes amid a larger recall effort involving other medications with quality defects.
The Ministry recently issued a nationwide recall of two medications: Enalapril Maleate USP 20mg Tablets (Batch No. 136802, expiring March 2027) and Acetylsalicylic Acid BP 300mg Tablets, commonly known as Aspirin (Batch Nos. ET240130, ET240131, ET240132, and ET240133, expiring May 2027).
The Enalapril Maleate tablets were found to disintegrate into small pieces or powder when opened, leading to a risk of underdosing and reduced therapeutic effectiveness.
The recall of Acetylsalicylic Acid tablets was triggered by reports of tablets clumping together and forming solid masses, which compromised their usability.
Minister Matsebula explained that these issues could arise from improper handling during packing or transportation.
Both recalls have prompted the Ministry’s Medicines Regulatory Unit (MRU) to initiate an investigation into the root causes of these defects.
Patients prescribed these medications were advised to check the batch or lot numbers on their packages and to inspect the tablets for the described defects.
If issues are detected, users should cease consumption and return the medication to the nearest health facility for safe disposal. Replacements will be provided where necessary.
The Minister stated that the Ministry continues to prioritize public safety and remains committed to addressing any quality concerns promptly.
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Matsebula emphasized that these proactive measures are critical to maintaining trust in the healthcare system and ensuring the availability of safe and effective medical products in Eswatini.