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Public Alert No. 0010/2021 – Falsified Vitamin A (Retinol) Identified In WHO Region of Africa

April 7, 2021,

The National Agency for Food and Drugs Administration and Control (NAFDAC) has been notified by World Health Organization (WHO) on the circulation of two versions of falsified VITAMIN A (retinol) identified in Chad. Laboratory analysis of recovered samples revealed that both products are severely degraded and contain less than the stated active ingredient.

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 implication for using 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.

Product details

Both versions of the falsified Vitamin A carry the outdated WHO Essential Drugs Programme logo and the outdated Micronutrient Initiative logo. Other details of the falsified products are as follows:

Product Name VITAMIN A (RETINOL) VITAMIN A (RETINOL)
Stated manufacturer Accucaps Industries Limited Banner Pharmacaps (Canada) Ltd
Stated active ingredient Vitamin A (USP) 200,000 I.U.

Vitamin E (USP) 40 I.U.

Vitamin A (USP) 200,000 I.U

Vitamin E (USP) 40 I.U.

Batch number UI4004 39090439
Mfg. date 01/2019 01/2019
Exp date 09/2022 09/2022
Packaging language English & French English & French
Identified in Chad Chad

Genuine Vitamin A (Retinol), batch UI4004, was manufactured by Accucaps Industries Limited in September 2009, with an expiry date of September 2012.

Genuine Vitamin A (Retinol) batch 39090439, was manufactured by Banner Pharmacaps (Canada) Ltd, with an expiry in 2009.

Hence The falsified Vitamin A (Retinol) identified in the above table and shown in the photos below have been tampered with and the manufacturing and expiry dates have been altered. Laboratory analysis has determined that the capsules had degraded and batch number UI4004   contain only 68.6% while batch 39090439 contain only 64.4% of the stated active ingredient.

Product image

Below are product images for ease of identification:

Falsified VITAMIN A (RETINOL), identified in Chad (Batch number UI4004)

Falsified VITAMIN A (RETINOL), identified in Chad (Batch number 39090439)

Recommendations

Consumers and patients are advised to obtain all medical products from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked before purchase.

All importers, wholesalers and retailers are implored to desist from illegal importation, distribution and sale of the falsified Vitamin A (retinol)

Health care providers and other members of the public are advised to be vigilant and contact the nearest NAFDAC office with any information on the falsified Vitamin A (retinol)

Anybody in possession of the falsified products should stop using them and submit them to the nearest NAFDAC office

Seek immediate medical advice from a qualified healthcare professional if you have used these products, or you suffered an adverse reaction/event having used these products.

Healthcare providers and Patients are advised to report adverse events and quality problems they experience with use of medicines and other medical products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLLS FREE from all networks), via pharmacovigilance@nafdac.gov.ng, the MedSafety app or via the e-reporting platform available on the NAFDAC website

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

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