KENYA—The Pharmacy and Poisons Board (PPB), Kenya’s drug regulator, has announced the recall of Benylin Pediatric 100ml cough syrup manufactured by Johnson & Johnson {Pty}, South Africa.

This action follows information received by PPB regarding the recall of Benylin Pediatric cough syrup batch No. 329304 by the National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria.

The affected batch of Benylin Pediatric 100ml syrup, manufactured in May 2021 with an expiry date of April 2024, is intended to relieve cough, hay fever, and allergies in pediatric patients.

NAFDAC’s decision for this recall was based on quality concerns arising from an unacceptable high level of diethylene glycol detected through laboratory analysis conducted by NAFDAC.

Diethylene glycol is a contaminant toxic to humans when consumed and can prove fatal, with effects including abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state, and acute kidney injury, potentially leading to death.

Upon receipt of this information, PPB has immediately commenced investigations, initiating a rapid response that includes sampling batches of Benylin Pediatric 100ml syrup within shelf life for screening levels of ethylene glycol and diethylene glycol.

PPB has advised all pharmaceutical outlets, healthcare facilities, healthcare workers, and the public to immediately quarantine the product and cease distribution, sale, issuing, or use.

The public has also been urged to return the product to the nearest healthcare facility, while healthcare facilities are advised to return the products to their respective suppliers.

The regulator also emphasized that this recall affects only BATCH NO. 329304 of Benylin Pediatric 100-ml syrup.

Individuals experiencing adverse reactions or events following the use of this product in children are advised to seek immediate medical attention from a qualified healthcare professional.

PPB went on to assure the public that it has established mechanisms to ensure that medicines supplied to the Kenyan market meet required quality, safety, and efficacy standards.

The PPB statement ended by encouraging vigilance and urging the public to report suspected poor-quality medicines or adverse drug reactions to the nearest healthcare facility and the Pharmacy and Poisons Board.

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