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Medical device warning no. 1/2021: Counterfeit vitamin A.

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Counterfeit VITAMIN A (retinol) identified in the WHO region of Africa

Warning Summary

This WHO medical product warning applies to two counterfeit VITAMIN A (retinol) capsules identified in Chad and reported to the WHO in November 2020. Laboratory analysis of the recovered samples found that both products were severely degraded and insufficiently dosed – containing less than of said active ingredient. Both counterfeit products also carry logos that are now obsolete – the outdated logo of the WHO Essential Medicines Program and the outdated logo of the Microelement Initiative. Both counterfeit products were delivered at the patient level and may still be in circulation in the region.

Vitamin A (retinol) is a micronutrient used to prevent and treat vitamin A deficiency. The most severe effects of this deficiency are observed in young children. Vitamin A deficiency is associated with significant morbidity and mortality from common childhood infections and is the world’s leading cause of preventable childhood blindness. Vitamin A deficiency also contributes to maternal mortality and other poor pregnancy and lactation outcomes. Retinol is listed by the WHO as an essential medicine for children.

The public health threat from counterfeit vitamin A (retinol) particularly affects vulnerable children who already suffer from vitamin A deficiency. It is important to detect and remove any counterfeit vitamin A (retinol) from the circulation to prevent harm to patients.

It is confirmed that the products identified in this warning are counterfeit on the grounds that they intentionally / fraudulently misrepresent their identity, composition or source:

  • the variable data (batch number and expiration dates) of these products do not correspond to the original production records;
  • the dates of manufacture and expiration of these products have been deliberately changed to extend their shelf life;
  • laboratory analysis of both products confirmed that both were insufficiently dosed, severely degraded and did not comply with the specifications.

Table 1: Products subject to WHO Medical Device Alert no. 1/2021

The original VITAMIN A (RETINOL), UI4004 series, was manufactured by Accucaps Industries Limited in September 2009, with an expiration date of September 2012. The counterfeit product identified in the table above and shown in the photos below was undermined and production and expiration dates changed . Laboratory analysis found that the capsules degraded and contained only 68.6% of said active ingredient. Furthermore, the label features two obsolete and obsolete logos (WHO Essential Drugs Program and Micronutrient Initiative).

The original VITAMIN A (RETINOL) 39090439 series was manufactured by Banner Pharmacaps (Canada) Ltd, which expired in 2009. The counterfeit product identified in the table above and shown in the photos below has been changed, and the production and expiration dates have been changed. Laboratory analysis found that the capsules degraded and contained only 64.4% of said active ingredient. Furthermore, the label features two obsolete and obsolete logos (WHO Essential Drugs Program and Micronutrient Initiative).

Advice to regulators and the public

The WHO is calling for greater vigilance within the supply chains of countries and regions that could be affected by these counterfeit products. Increased vigilance should include hospitals, clinics, health centers, wholesalers, distributors, pharmacies and all other suppliers of medical devices.

All medical devices must be obtained from authorized / licensed suppliers. The authenticity and physical condition of the product should be carefully checked. If in doubt, seek advice from a healthcare professional.

If you own the above counterfeit products, do not use them.

If you have used these products or have experienced an adverse reaction / event if you have used them, it is advisable to seek medical advice immediately from a qualified healthcare professional and to report the incident to the national regulatory authorities / National Pharmacovigilance Center.

National regulatory / health authorities are advised to notify the WHO immediately if these counterfeit products are detected in their country. If you have any information regarding the production, distribution or supply of these products, please contact [email protected]

Table 2: Photographs of products subject to WHO Medical Device Alert no. 1/2021

Table 2 Counterfeit retinol A

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