NAFDAC recalls Benylin paediatric syrup over ‘toxicity’


 The National Agency for Food and Drugs Administration and Control (NAFDAC) has recalled Benylin paediatric syrup manufactured by Johnson & Johnson over safety concerns.

 

Benylin paediatric syrup is used for the relief of cough, and congestive symptoms.

The syrup is also applied in the treatment of hay fever and other allergic conditions in children aged two to 12 years.

 

A product recall is a request to return to the maker, a batch, or an entire production run of a product, usually over safety concerns, design defects, or labelling errors.

 

In a statement on Wednesday, NAFDAC said laboratory analysis conducted on the syrup showed that it contains an unacceptable high level of diethylene glycol which is toxic to humans when consumed and can prove fatal.

 

The agency said the medicine was also found to cause acute oral toxicity in laboratory animals.

 

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

 

”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 the 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: sf.alert@nafdac.gov.ng.

 

 “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 pharmacovigilance@nafdac.gov.ng.

 

“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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