The Rwanda Food and Drug Authority has suspended the use of Batch No. 329304 of Benylin Pediatrics Syrup manufactured by Johnson & Johnson, South Africa.
In the recall notification, the Rwanda FDA stated that reference is made to the public alert No. 013/2024 dated April 10th, 2024, issued by the Nigerian National Agency for Food and Drugs Administration and Control (NAFDAC), notifying the recall of Batch No.329304 of Benylin Pediatrics Syrup manufactured by Johnson & Johnson (Pvt).
NAFDAC states that “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,” which may pose a toxicity risk to humans.
The Rwanda FDA instructs all importers, central medical stores, wholesalers, RMS branches, retailers, and public and private health facilities to stop the distribution and dispensing of batch No. 329304 of Benylin Pediatrics Syrup manufactured by Johnson & Johnson (Pvt).
The FDA reminds the importers and suppliers of batch No. 329304 of Benylin Pediatrics Syrup manufactured by Johnson & Johnson (Pvt), South Africa, to report to the Rwanda FDA within 3 working days from the date of publication of this recall, the quantities imported, quantities distributed, quantities returned, and final stock on hand.
“Anyone in possession of the mentioned batch of Benylin Pediatrics Syrup is advised to stop using the medicine,” Rwanda FDA stated in the statement.
Benylin Pediatric syrup is indicated for the relief of cough and its congestive symptoms and the treatment of hay fever and other allergic conditions in children aged 2 to 12 years.