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NAFDAC recalls Nigeria’s cough medicine for children, Benylin cough syrup

Benylin Paediatrics Syrup, one of Nigeria’s popular cough medicines for children, has been recalled by the National Agency for Food and Drugs Administration and Control, NAFDAC.

 

The product, manufactured by Johnson & Johnson, was said to contain an unacceptably high level of Diethylene glycol. It was found to cause acute oral toxicity in laboratory animals.

In a statement published on its website, NAFDAC explained the decision to recall the syrup was taken after its thorough laboratory analysis.

The Agency has directed the Marketing Authorization Holder (Johnson and Johnson company West Africa) to initiate the recall of the batch and the notice will also be uploaded to the WHO Global Surveillance and Monitoring System, GSMS.

The statement reads in part, “The National Agency for Food and Drugs Administration and Control, NAFDAC, is notifying the public of the recall of one lot of Benylin Paediatrics Syrup manufactured by Johnson & Johnson, following recent toxicity findings in the laboratory on the product.

“Laboratory analysis conducted on the product showed that it contains an unacceptable high level of Diethylene glycol and was found to cause acute oral toxicity in laboratory animals.

“Benylin Paediatric syrup is indicated for the relief of cough and its congestive symptoms. And for the treatment of hay fever and other allergic conditions in children aged two to 12 years.

“Diethylene glycol is toxic to humans when consumed and can prove fatal.

Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.

“The details of the affected product are shown below:

“Product name: Benylin Paediatric; manufacturer: Johnson 241, Main Road, Retreat Cape Town, 7945.

“Importer: Johnson and Johnson Company West Africa, Batch number, 329304. Manufacturing date: May 2021, and Expiry date, April 2024.

“NAFDAC implores importers, distributors, retailers and consumers to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and use of the substandard (contaminated) regulated products.

“All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.

“Anyone in possession of the above-mentioned product is advised to immediately discontinue sale or use and submit stock to the nearest NAFDAC office.

“If you witness any adverse reaction/event after the use of this product in any children, you are advised to direct such patients for immediate medical attention from a qualified healthcare professional.

“Healthcare professionals and consumers are advised to report any suspicion of substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: [email protected].

“Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of the medicinal product to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med-safety application available for download on android and IOS stores or via e-mail on [email protected].

“The Agency has directed the Marketing Authorization Holder (Johnson and Johnson company West Africa) to initiate the recall of the batch and the notice will also be uploaded to the WHO Global Surveillance and Monitoring System, GSMS.”

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