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NAFDAC recalls Johnson & Johnson’s Benylin Paediatrics Syrup over toxicity concerns

Agency Urges Caution and Vigilance Amidst Product Safety Alert

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The National Agency for Food and Drugs Administration and Control (NAFDAC) has initiated a recall of Benylin Paediatrics Syrup, manufactured by Johnson & Johnson, due to recent laboratory findings indicating toxicity in the product.

In a statement released on its website, NAFDAC revealed that laboratory analysis of the syrup detected an unacceptably high level of Diethylene glycol, a substance known to cause acute oral toxicity in laboratory animals.

A product recall, NAFDAC emphasized, is a crucial measure for managing risks associated with product safety events and emergencies, particularly when safety concerns, design defects, or labeling errors arise.

The recalled batch, with number 329304, was manufactured in May 2021 in Cape Town, South Africa, and is set to expire in April 2024.

Highlighting the dangers of Diethylene glycol consumption, NAFDAC warned of potential fatal consequences, including abdominal pain, vomiting, diarrhea, altered mental state, and acute kidney injury.

Importers, distributors, retailers, and consumers were urged to exercise caution and vigilance within the supply chain to prevent the importation, distribution, sale, and use of substandard or contaminated products.

NAFDAC stressed the importance of obtaining medical products from authorized and licensed suppliers, emphasizing the need to verify product authenticity and physical condition carefully.

Individuals in possession of the recalled product were advised to discontinue its sale or use immediately and submit remaining stock to the nearest NAFDAC office. Any adverse reactions or events following the use of the product should be reported promptly to qualified healthcare professionals.

Healthcare professionals and consumers were encouraged to report suspicions of substandard or falsified medicines, as well as adverse events related to product use, to NAFDAC through various reporting channels provided by the agency.

As the regulatory body overseeing the manufacture, importation, distribution, and use of various products, including food, drugs, cosmetics, and medical devices, NAFDAC remains committed to ensuring public health and safety.

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