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Medical Product Warning no. 9/2019 (English version)
Counterfeit Augmentin found in Uganda and Kenya
This medicinal product alert is for a certified counterfeit Augmentin (amoxicillin trihydrate – potassium clavulanate) found in Uganda and Kenya. It should be noted that this is the second WHO medical device alert issued on counterfeit Augmentin in the African region. First WHO medical device alert no. 2/2018 it was released on March 2, 2018.
True amoxicillin + clavulanic acid has been used to treat a range of bacterial infections and has been listed on the WHO Essential Medicines List as the antibiotic of the accession group.
The WHO recently notified the Uganda National Medicines Authority that counterfeit Augmentin at the patient level in Uganda has been detected by regular post-marketing surveillance of the quality of medicinal products on the market. Samples were sent for laboratory assurance testing and did not reveal any of the expected active ingredients. The Kenya Board of Pharmacy and Poisons has confirmed that the same group of counterfeit Augmentin was previously found at the patient level in Kenya.
The product details are listed in Table 1 below and are contained in Report of the National Medicines Agency of Uganda
It should be noted that:
- The manufacturer stated that it did not produce this counterfeit version.
- Laboratory analysis of quality assurance did not identify any of the expected active ingredients.
- At this stage, no NHS have been reported.
- There are inconsistencies in labeling and packaging.
Photos and tips for the public are available below.
The WHO requires greater caution in the supply chains of countries likely to be affected by this counterfeit medical device. Increased alertness should include hospitals, clinics, health centers, wholesalers, distributors, pharmacies and all other suppliers of medical devices.
If you own the above specific product, do not use it. If you have taken this counterfeit medical device or suffered an adverse event or unexpected lack of efficacy, seek the advice of a qualified healthcare professional immediately and ensure that they report the incident to your local Ministry of Health / National Medicines Regulatory Authorities. National Pharmacovigilance Center.
All medical products must be obtained from credible and reliable sources. Their authenticity and condition should be carefully checked. If in doubt, seek the advice of a healthcare professional.
National health authorities ask you to notify WHO immediately if this counterfeit medical device is discovered in their country. If you have any information on the production, distribution or supply of this medical device, please contact [email protected]
WHO Global Surveillance and Surveillance System
for substandard and counterfeit medical products
For more information, visit: http://www.who.int/medicines/regulation/ssffc/en/
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