Falsified VITAMIN A (retinol) identified in WHO region of Africa

Alert Summary 

This WHO Medical Product Alert refers to two falsified VITAMIN A (retinol) capsules identified in Chad and reported to WHO in November 2020. Laboratory analysis of recovered samples identified that both products are severely degraded and underdosed – containing less than the stated active ingredient. Both falsified products also carry now-defunct logos – the outdated WHO Essential Drugs Programme logo and the outdated Micronutrient Initiative logo. Both falsified products were supplied at patient level and may still be in circulation in the region.

Vitamin A (retinol) is a micronutrient used for the prevention and treatment of vitamin A deficiency. The most severe effects of this deficiency are seen in young children. Deficiency of vitamin A is associated with significant morbidity and mortality from common childhood infections and is the world’s leading preventable cause of childhood blindness. Vitamin A deficiency also contributes to maternal mortality and other poor outcomes of pregnancy and lactation. Retinol is listed on the WHO Model List of Essential Medicines for Children.

The public health threat of falsified vitamin A (retinol) particularly affects vulnerable children already suffering from vitamin A deficiency. It is important to detect and remove any falsified vitamin A (retinol) from circulation so as to prevent harm to patients. 

The products identified in this Alert are confirmed falsified on the basis that they deliberately/fraudulently misrepresent their identity, composition, or source:

• the variable data (batch number and expiry dates) of these products do not correspond to genuine manufacturing records; 
• the manufacturing and expiry dates of these products have been deliberately altered to extend their shelf-life; 
• laboratory analysis of both products have confirmed both are underdosed, severely degraded, and do not comply with specifications.