NAFDAC Recalls Benylin Pediatric Syrup Over Toxicity Concerns

The National Agency for Food and Drugs Administration and Control (NAFDAC) has issued an urgent recall for Johnson & Johnson’s Benylin Pediatric Syrup.

Naija News reports that the decision follows alarming laboratory findings indicating a dangerously high level of Diethylene glycol in the syrup, posing serious health risks.

In a detailed announcement on its website on Wednesday, NAFDAC revealed the toxicity results, highlighting the substance’s lethal potential when consumed by humans.

The agency disclosed that Diethylene glycol’s adverse effects include severe abdominal pain, vomiting, diarrhoea, urinary retention, headaches, altered mental status, and acute kidney injury, which could lead to fatal outcomes.

The affected product, designed for alleviating cough, congestion, hay fever, and other allergic conditions in children between two to 12 years, is identified by batch number 329304.

Reports suggest that the concerned product was manufactured in Cape Town, South Africa, by Johnson & Johnson in May 2021, with an expiration date set for April 2024.

NAFDAC’s warning extends to importers, distributors, retailers, and consumers, urging heightened vigilance to prevent the circulation of this substandard product.

The agency advised that all medical products should be sourced from authorized channels and subjected to thorough verification for authenticity and quality.

It further called on pharmacists to cease the sale or usage of this product immediately and report any stock to the nearest NAFDAC office.

Furthermore, healthcare professionals and consumers are encouraged to report any adverse reactions or events related to the syrup’s use to NAFDAC through various reporting platforms provided on their official website or the Med-safety application.

The directive also includes the immediate initiation of the recall process for the implicated batch by the marketing authorization holder, Johnson & Johnson company, West Africa.