This Medical Product Alert relates to falsified versions of Multi dose (10ml) Hepatitis B Vaccines (rDNA) that have been identified in Uganda and recently reported to WHO.
This vaccine is used to prevent infection by Hepatitis B virus (HBV) and is a WHO prequalified product in its genuine version manufactured by the Serum Institute of India Pvt. Ltd.
HBV is a potentially life-threatening viral infection that attacks the liver and can cause both acute and chronic disease. HBV is a major global health problem. WHO recommends that all infants receive the vaccine as soon as possible after birth.
WHO was recently informed by the Uganda National Drug Authority (NDA) that this falsified vaccine was available at patient level in a number of locations in the Central, South-Western and Eastern regions in Uganda. Investigations are ongoing and samples are currently being collected for full laboratory analysis. The source(s) of the falsified product has not yet been identified.
It should be noted that:
- The stated manufacturer has confirmed the below products are falsified based on label inconsistencies;
- There have been no known adverse reactions reported to WHO at this stage.
Falsified versions of 10 different batch numbers have been discovered.
Product details and photographs are available here.
WHO requests increased vigilance within the supply chains of countries likely to be affected by this falsified product. Increased vigilance should include hospitals, clinics, health centres, wholesalers, distributors, pharmacies and any other suppliers of medical products.
If you are in possession of the above product, please do not use. If you have taken this falsified product, or if you suffer from an adverse event after having taken this product, please seek immediate advice from a qualified healthcare professional, and report the incident to your local Ministry of Health/National Medicines Regulatory Authorities/National Pharmacovigilance Centre.
It is necessary to ensure that all medical products are obtained from authentic and reliable sources. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional if there is any doubt.
National health authorities are asked to immediately notify WHO if this falsified product is discovered in their country. If you have any information concerning the manufacture, distribution, or supply of these products, please contact rapidalert@who.int