Public Alert No. 041/2022 – Recall of substandard dexamethasone products detected in Anambra State, Nigeria

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The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying Healthcare providers and the public of the recall of substandard dexamethasone tablets detected in Anambra State.

This recall is due to unsatisfactory results of analysis which showed that the samples were found to contain substandard amounts of dexamethasone (i.e. less than the amount stated on the labels). Some of the samples were also found to contain methylparaben and/or propylparaben in small amounts. Methylparaben and/or propylparaben is a preservative often used to give a product a longer shelf life. The presence of these preservatives in tablets are unusual and unnecessary and the use of these substances should be avoided, particularly in case of paediatric formulations.

Dexamethasone provides relief for inflamed areas of the body. It is used to treat a number of different conditions, such as inflammation (swelling), severe allergies, adrenal problems, arthritis, asthma, blood or bone marrow problems, kidney problems, skin conditions, and flare-ups of multiple sclerosis.

Possible Risk

The administration of the subtherapeutic doses of dexamethasone in the products or any substandard and falsified medical products may cause harm to patients and lead to treatment failure. They can also lead to loss of confidence in medicines, healthcare providers and health systems.

Consequently, NAFDAC has directed all concerned Marketing Authorization Holders (MAH) of the affected brands to initiate a nationwide recall of their products with immediate effect and submit updates of the recall to the Agency for effective monitoring.  

Product Details

The details of the substandard dexamethasone tablets are listed below;

NAFDAC has heightened surveillance in the 36 States and the Federal Capital Territory, Abuja to  stop the distribution and sale of the above listed dexamethasone products.

All distributors, wholesalers, retailers and consumers in possession of the recalled products are implored to discontinue sale or use and submit stock to the nearest NAFDAC office.

Healthcare providers and other members of the public are to contact the nearest NAFDAC office with any information on distribution and sale of the recalled dexamethasone products.

Healthcare professionals and consumers are advised to report any suspicion of adverse drug reaction, substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng

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

Signed Management